MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN GAMMA3 LAG SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2023

Event Type  Injury  

Event Description

As described by rep below: "i attended a surgery on (b)(6) 2023.It was a revision gamma nail for a 13x440 gamma in an elderly male patient.The lag screw missed the nail and consequently a revision surgery was needed.Following surgery the staff and surgeon informed me the patient was not doing well and may not make it.It was suggested that all gamma nail sets on site were checked which will happen over the course of a few weeks and i am in close contact with staff on site to ensure this is completed." update (b)(6) 2023: it has been confirmed that the patient has died after the revision surgery was performed.This record captures the intra-op misdrilling that resulted in the incorrect placement of the lag screw that lead to the revision surgery and patients death (captured under stryker reference # (b)(4)).

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.

• Brand Name: UNKNOWN GAMMA3 LAG SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18431654
• MDR Text Key: 331864149
• Report Number: 0009610622-2024-00009
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• 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