MAUDE Adverse Event Report: STRYKER GMBH G4 PROX.TARGETING ARM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 14200100

Device Problems Crack (1135); Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that during use of the targeting arm the lag screw reamer missed the nail and broke.The surgeon was really wrenching on the arm trying to get the reamer to pass, which might have led to a crack in the targeter.According to additional information received the "surgeon opened 2nd reamer that continued to miss the nail - something was off the with the targeting arm.The surgeon hammered the reamer in, to proceed with the case.Surgeon was able to get the wider part of the reamer in.".

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: G4 PROX.TARGETING ARM
• 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: 18793224
• MDR Text Key: 336402504
• Report Number: 0009610622-2024-00087
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14200100
• Device Lot Number: KP482769
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1