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	07/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the following: "during insertion of the pin, the threaded portion broke in the femoral head.Extraction of the part was not performed, and a piece of pin was left implanted in the patient.Clinical consequence and current condition of the patient: none.Actions taken for the patient regarding the md: pin replacement and no consequences for the rest of the procedure.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged issue.The device inspection revealed the following: the received k-wire was found to be broken around the tip.Overall, the k-wire appears to have been put under significant duress as apparent by multiple circular damage across the length, indicating towards interaction with the sleeve under rotation.The breakage surface indicates towards a combination of ductile as well as brittle failure, evident by deformation around the edges and clear surface at the center, respectively.Most likely the k-wire was put under a significant bending and axial loading, leading to such a breakage.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the issue is deemed to be user related.The nature of breakage indicates towards application of excessive bending and axial loading during use, evident also by multiple damage apparent on the surface of the k-wire.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported the following: "during insertion of the pin, the threaded portion broke in the femoral head.Extraction of the part was not performed, and a piece of pin was left implanted in the patient.Clinical consequence and current condition of the patient: none actions taken for the patient regarding the md: pin replacement and no consequences for the rest of the procedure." update (b)(6) 2025."¿ were there any hard bones? insertion of the pin into the femoral shaft after bone trepanation.¿ how long was the item used (approximately)? a few seconds/minutes, until the tip of the pin broke off inside the femoral head.".

• 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: 22885591
• Report Number: 0008031020-2025-01423
• Device Sequence Number: 4915664
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: (01)04546540175366(17)300228(10)K10C20A
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: K10C20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown