MAUDE Adverse Event Report: STRYKER GMBH BIXCUT - IM REAMER, MOD. TRINKLE FITTING D8.0X480MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02276080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received device was visually inspected, revealing that the reamer is broken into two fragments at the end of the flexible section near the weld.The deformation at the cutting edges is severe, with many pits indicating material has been chipped out of the position.The deformation suggests abnormal handling of the device.The breakage appears brittle, as there is no visible plastic deformation; it was likely caused by high torsional force applied to the deformed cutting edges.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 root cause can be attributed to user related as the deformation on the cutting flutes is heavy, causing the application of high force.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the shaft broke during medullary canal reaming.It was used correctly and there was no reverse rotation.".

• Brand Name: BIXCUT - IM REAMER, MOD. TRINKLE FITTING D8.0X480MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23550490
• Report Number: 0008031020-2025-02072
• Device Sequence Number: 9448674
• Product Code: LXH
• UDI-Device Identifier: 04546540145802
• UDI-Public: 04546540145802
• 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
• Report Date (Section B): 11/13/2025

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: 02276080
• Device Lot Number: K1B26FF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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 Age: 26 YR
• Patient Sex: Male