MAUDE Adverse Event Report: STRYKER GMBH BIXCUT - IM REAMER, MOD. TRINKLE FITTING D10.0X480MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02276100
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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 reamer was used to widen the femoral marrow cavity.It was defeated by the hard bone and the shaft portion was bent.The reamer was not broken, so no metal or other object was implanted in the body.".
Additional Manufacturer Narrative
The reported event could be confirmed as the device was returned and matches the alleged event.Upon visual inspection of the returned device, it was observed that the device is deformed from its original shape, exhibiting bends at multiple locations.Additionally, the spacing between the coils in the flexible section has increased in the areas affected by the bending.This pattern of deformation suggests that the device encountered resistance from a rigid structure, likely a hard bone, while torsional force was still being applied, resulting in bending within the flexible region.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 is attributed to user-related factors, as the device is deformed at multiple sections with application of high force while being hit by the rigid surface, like a hard bone in this event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the reamer was used to widen the femoral marrow cavity.It was defeated by the hard bone and the shaft portion was bent.The reamer was not broken, so no metal or other object was implanted in the body.".

• Brand Name: BIXCUT - IM REAMER, MOD. TRINKLE FITTING D10.0X480MM
• 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: 22310689
• Report Number: 0008031020-2025-00995
• Device Sequence Number: 12761748
• Product Code: LXH
• UDI-Device Identifier: 04546540145840
• UDI-Public: (01)04546540145840(10)K1D9C16
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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
• Device Catalogue Number: 02276100
• Device Lot Number: K1D9C16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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