MAUDE Adverse Event Report: STRYKER GMBH T2 - UNIVERSAL ROD D9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060110
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
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
Once the investigation is completed, any additional information will be reported in a supplemental report.
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 universal rods were found damaged.Initial threads are flattened due to repetitive impact loading, and there are damage marks in the base of threaded portion of shafts.The damage marks in the shafts indicate strong contact with the mating part due to excessive hammering over a period of time.Excess hammering resulted in minor adhesion of the threads with mating part and when the threads were disengaged, they got worn out and damaged.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 of the device inside the mating part over a period of usage.It is also very important to ensure that the threads of the mating part should not be damaged or deformed, as in such a case, inserting the the device forcefully followed by hammering could also lead to thread damage of device.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 - UNIVERSAL ROD D9 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: 22872688
• Report Number: 0008031020-2025-01408
• Device Sequence Number: 10386850
• Product Code: LXH
• UDI-Device Identifier: 04546540196019
• UDI-Public: 04546540196019
• 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: 18060110
• Device Lot Number: K1B9CB8
• 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: 06/28/2024
• 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