MAUDE Adverse Event Report: STRYKER GMBH GUIDE WIRE HANDLE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23510030
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "broken instrument." no additional information was provided.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed as device was not returned and no other evidence were provided.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.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "broken instrument." no additional information was provided.
Additional Manufacturer Narrative
Corrections: please refer to section d9/h3 the device was returned and h6 (methods, results and conclusion codes).The reported event could be confirmed as device was returned and matches to the alleged event.The returned guidewire handle was visually inspected, revealing that it is broken at the assembly section of the adjustment wheel.A close examination of the breakage surface indicates that the break is brittle, as we don¿t see any plastic deformation, which may have been caused by the application of high torsional force during the wheel assembly, as the adjustment wheel is stuck in the broken fragment.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 above investigation root cause can be pertained to user related as the breakage happened at the assembly section of adjustment wheel indicating to application of high torsional force.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "broken instrument." no additional information was provided.

• Brand Name: GUIDE WIRE HANDLE IMN INSTRUMENTS
• 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: 20665418
• Report Number: 0009610622-2024-00908
• Device Sequence Number: 20958027
• Product Code: LXH
• UDI-Device Identifier: 07613327361674
• UDI-Public: 07613327361674
• 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,Followup
• Report Date (Section B): 06/30/2025

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: 23510030
• Device Lot Number: KME920046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 06/05/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/20/2024; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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