MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X105MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30600105S

Device Problem Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Date 09/03/2014

Event Type  Injury  

Manufacturer Narrative

The reported event lag screw, ti gamma3® ø10.5x105mm was alleged revised could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information is not available.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device not available to stryker.

Event Description

The manufacturer became aware of adverse events from the (b)(4) hip fracture register.The title of this report is ¿gamma 3 in the (b)(4) hip fracture register¿ which is associated with the gamma3 locking nail system, within that report, postoperative complications/ adverse events were reported, which occurred between 1-jan-2005 and 31-dec-2016.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 290 complaints were initiated for the revision surgeries retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision surgery due to nonunion.The patient received a hip bipolar hemiarthroplasty.Seventy-nine out of 290 cases.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X105MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7746389
• MDR Text Key: 115902405
• Report Number: 0009610622-2018-00464
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540374950
• UDI-Public: 04546540374950
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 30600105S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention