MAUDE Adverse Event Report: STRYKER GMBH STRIKE PLATE T2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060150
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
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: "the surgeon had partially inserted the nail (attached to jig).He then decided to remove the nail - strike plate attached to jig and universal rod attached to strike plate, using slotted hammer to backslap.The strike plate and universal rod construct became detached, with the threads of the strike plate remaining in the jig.Outcome: the surgeon removed the strike plate threads from the jig, i believe using a generic 3mm wire.He then inserted the universal rod directly into the jig to act as a strike plate to reinsert the nail.Estimated delay: less than 1 minute.".
Additional Manufacturer Narrative
Correction: please refer to section d9, the device was not returned.The device was not returned for inspection.Nonetheless, the photo received clearly shows that the device's tip is broken and that a fragment has been detached, confirming the reported event.It must the noted that the lot number is not visible on the photo.Despite the confirmation of the event, it was not possible to determine its root cause.The return of the instrument for a complete inspection or at least clear pictures of the breakage area would have been necessary.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the surgeon had partially inserted the nail (attached to jig).He then decided to remove the nail - strike plate attached to jig and universal rod attached to strike plate, using slotted hammer to backslap.The strike plate and universal rod construct became detached, with the threads of the strike plate remaining in the jig.Outcome: the surgeon removed the strike plate threads from the jig, i believe using a generic 3mm wire.He then inserted the universal rod directly into the jig to act as a strike plate to reinsert the nail.Estimated delay: less than 1 minute.".

• Brand Name: STRIKE PLATE T2
• 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: 21734862
• Report Number: 0008031020-2025-00492
• Device Sequence Number: 8635614
• Product Code: LXH
• UDI-Device Identifier: 04546540196088
• UDI-Public: 04546540196088
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 18060150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 32 YR
• Patient Sex: Male