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

Catalog Number	02276080
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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
Broken during diaphyseal reaming.Used in reverse rotation.Update september 18, 2025.How was the event resolved? the 8.0mm reamer broke, so an 8.5mm reamer was used instead.The reamer was removed by backstroking it with pliers and a hammer.If the device was broken or damaged: was there hard/dense bone? unknown but patient was in their 40's so, it was not soft.Was there any debris reported? were they all removed from the surgical field/patient? no fragments were visible to the naked eye.X-rays were taken during and post-surgery, but no fragments were found.
Event or Problem Description
Broken during diaphyseal reaming.Used in reverse rotation.Update september 18, 2025.How was the event resolved? the 8.0mm reamer broke, so an 8.5mm reamer was used instead.The reamer was removed by backstroking it with pliers and a hammer.If the device was broken or damaged: was there hard/dense bone? unknown but patient was in their 40's so, it was not soft.Was there any debris reported? were they all removed from the surgical field/patient? no fragments were visible to the naked eye.X-rays were taken during and post-surgery, but no fragments were found.
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned reamer was confirmed based on the catalog # and the lot # marked.The instrument is broken in two parts, both parts have been returned.The part is severely deformed and shows significant signs of wear, such as scratches and notches.The breakage point at the beginning of the shaft indicates high torsional forces, as the material has been torn off in a spiral pattern.This deformation of the material is an indication of high forces acting on it, resulting in a ductile fracture.Based on investigation, the root cause was attributed to an user related issue.It was reported that the reamer was used in reverse rotation.Given that the fracture occurred at the beginning of the shaft, it could be concluded that the breakage was caused by excessive torsional being applied to the reamer, most probably using a power tool.In this case, please refer to: bixcut instructions for use l22000065 rev ab, 06-2022 7.2 intra-operative.Never operate an intramedullary reamer in a counter-clockwise direction.Doing so causes the reamer shaft spiral to open and may lead to additional trauma.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.If more information is provided, the case will be reassessed.

• 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: 23316688
• Report Number: 0008031020-2025-01932
• Device Sequence Number: 17353076
• 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,Followup
• Report Date (Section B): 02/03/2026

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: K0187DA
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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