MAUDE Adverse Event Report: STRYKER GMBH BIXCUT - IM REAMER, MOD. TRINKLE FITTING D7.5X480MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02276075
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
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: "when reaming the spinal canal starting at 7.5mm as per the procedure, the tip of the reamer broke off.".
Additional Manufacturer Narrative
Correction: please refer to section h6 health impact 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: reamer was received and found broken from its distal end.The reamer is broken from spiral portion above the cutting edges.Deep scratch marks are visible both on the outer and internal periphery of the shaft near the broken portion.It looks like the reamer had excess contact most probably with the guide wire during usage.Burning marks of friction due to excess contact are also visible on the internal periphery of the device.This excess contact disrupted forward motion of the reamer and resulted in excess torsional and bending force due to which it got broken.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, the root cause was attributed to a user related issue as the breakage was caused by the application of excess torsional and bending force.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when reaming the spinal canal starting at 7.5mm as per the procedure, the tip of the reamer broke off.".

• Brand Name: BIXCUT - IM REAMER, MOD. TRINKLE FITTING D7.5X480MM
• 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: 23223938
• Report Number: 0008031020-2025-01675
• Device Sequence Number: 9440852
• Product Code: LXH
• UDI-Device Identifier: 04546540145796
• UDI-Public: (01)04546540145796(10)K11BDAD
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/25/2026

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: 02276075
• Device Lot Number: K11BDAD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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