MAUDE Adverse Event Report: STRYKER GMBH CLOSED TUBE CLIP GAMMA3; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200125
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The returned device underwent a visual inspection.We can see that the fragment of the closed tube clip is broken on one side and was not returned for investigation.The breakage occurred in a brittle manner, which is evident from the breakage pattern, as it is flat with no signs of plastic deformation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.Based on the investigation, the root cause was attributed to a user-related issue.The failure was caused by the application of excessive force during the handling of the device, most likely either during surgery or transportation sterilization.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A broken instrument was sent back.

• Brand Name: CLOSED TUBE CLIP GAMMA3
• 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: 22150443
• Report Number: 0008031020-2025-00943
• Device Sequence Number: 8468530
• Product Code: LXH
• UDI-Device Identifier: 04546540508003
• UDI-Public: (01)04546540508003(10)K031903
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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: 13200125
• Device Lot Number: K031903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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
• Patient Sex: Unknown