MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - K-WIRE D3.2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	12106450S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that during surgery, the tip of a stryker k-wire snapped off and retained in patient's femoral bone.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the correction to h6 device code.The reported event could not be confirmed since the affected device was not returned and no other evidence was share for evaluation.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are quired at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labelling did not indicate any abnormalities.More information, as well as the affected device, musty be available in order to determine the exact root cause of the issue.If the device is returned, or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the customer that during surgery, the tip of a stryker k-wire snapped off and retained in patient's femoral bone.

• Brand Name: GAMMA3 - K-WIRE D3.2X450 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22950443
• Report Number: 0008031020-2025-01447
• Device Sequence Number: 9636110
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: (01)04546540175366(17)291231(10)K0FF3BA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 12106450S
• Device Lot Number: K0FF3BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown