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

Catalog Number	18060150
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2025
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: "on monday morning the (b)(6) 2025 a nurse reached out to rep to advise her that several instruments had broken threads.The instruments had been used during cases over the weekend and now looked damaged.The rep went to inspect all the instruments that are consigned and noticed several being broken.No issues were noted during these cases and no impact on surgical time or outcomes have been reported.Issue was noted after procedures.It's uncertain when the damage occurred.".
Additional Manufacturer Narrative
Correction: please refer to section h6 (device code).The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: threads of the strike plates were found severely damaged.The threads are flattened, and the upper layer is damaged.Base of the threaded portion shows marks of excess contact most probably with the base of the target device due to hammering.It looks like the damage on the threads happened because the threads were not aligned properly with the mating threads, overtightening was done followed by hammering.This caused the threads to press against each other too tightly and joining with each other, during disassembly, the threads torn off.A functional inspection was done on the returned target device and strike plate, and it was found that the assembling/ disassembling was very difficult due to thread 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 or manufacturing related problems were found during the investigation.Based on the investigation, the root cause was attributed to be a user related issue.The event was caused by over torquing and hammering the misaligned strike plate inside the mating part.It is also very important to ensure that the threads of the mating part (mostly target device) should not be damaged or deformed, as in such a case, inserting the strike plate forcefully followed by hammering could also lead to thread damage of strike plate.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "on monday morning the 28/07 a nurse reached out to rep to advise her that several instruments had broken threads.The instruments had been used during cases over the weekend and now looked damaged.The rep went to inspect all the instruments that are consigned and noticed several being broken.No issues were noted during these cases and no impact on surgical time or outcomes have been reported.Issue was noted after procedures.It's uncertain when the damage occurred.".

• Brand Name: T2 - STRIKE PLATE
• 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: 22872690
• Report Number: 0008031020-2025-01410
• Device Sequence Number: 10386851
• Product Code: LXH
• UDI-Device Identifier: 04546540196088
• UDI-Public: (01)04546540196088(10)K1A3652
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 11/25/2025

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: K196C29
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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