Events

Safety Alert for Locking Compression Plate Drill Sleeve 1.5 f/Drill Bit ø1.1mm

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Synthes GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-08-15
  • Event Date Posted
    2017-08-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170815.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: synthes gmbh locking compression plate drill sleeve 1.5 f/drill bit ø1.1mm medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its locking compression plate (lcp) drill sleeve 1.5 f/drill bit ø1.1mm. [part number: 03.114.001; lot numbers: 9972971, h028400, h161606, h288454]. the manufacturer is initiating a voluntary field safety notification for the above lots of the lcp drill sleeve which is part of the 1.5 mm lcp modular mini fragment system. the lcp compact hand 1.5 implants are intended for temporary fixation, correction or stabilization of bones in anatomical region of the hand. drill/protection guide/sleeves are intended for holding and guiding implants and instruments during orthopaedic surgery. according to the manufacturer, there may be difficulty attaching the affected lots of the drill sleeve to the plate. if the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. additionally, if the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening. affected users are not required to return the synthes lcp drill sleeves. they are advised to pre-assemble the drill sleeve with the plate preoperatively. if they experience difficulty connecting the drill sleeve to the plate, they should use the additional 1.1 mm locking drill sleeve provided in the graphic case, or: align the 1.1 mm drill bit to the plate as perpendicular as possible and then drill freehand and the locking screw can be engaged in this manner. if the drill hole must be used and no option to lock remains, a non-locking screw can be used. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 august 2017.

Device

Locking Compression Plate Drill Sleeve 1.5 f/Drill Bit ø1.1mm
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes GmbH Locking Compression Plate Drill Sleeve 1.5 f/Drill Bit ø1.1mm
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH