MAUDE Adverse Event Report: STRYKER GMBH K-WIRE GAMMA3 Ø3,2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	12106450
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "scheduled gamma nail removal surgery.A guide pin was inserted to remove the lag screw, but the lag screw did not pull out properly and the guide pin also got stuck.When surgeon tried to pull out the guide pin with pliers, tip of it broke off.Surgeon tried again to pull out the lag screw with a screwdriver and was able to pull it out without any problem.There were no residuals in the patient's body.".
Event or Problem Description
As reported: "scheduled gamma nail removal surgery.A guide pin was inserted to remove the lag screw, but the lag screw did not pull out properly and the guide pin also got stuck.When surgeon tried to pull out the guide pin with pliers, tip of it broke off.Surgeon tried again to pull out the lag screw with a screwdriver and was able to pull it out without any problem.There were no residuals in the patient's body.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the received k-wire was found to be broken from the junction where the threaded tip starts.The nature of breakage is not completely brittle as there is some deformation observed at the breakage point.The deformation is towards a particular angulation indicating towards a non-axial load application while it is stuck.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 investigation, the root cause of the issue is deemed to be user related.The nature of breakage indicates towards a non-axial application of load which most likely was applied during its removal.If any additional information is provided, the investigation will be reassessed.

• Brand Name: K-WIRE GAMMA3 Ø3,2X450 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21894465
• Report Number: 0008031020-2025-00747
• Device Sequence Number: 3442830
• Product Code: LXH
• UDI-Device Identifier: 04546540175359
• UDI-Public: (01)04546540175359(10)K1B36AD
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 12106450
• Device Lot Number: K1B36AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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
• Patient Sex: Unknown