MAUDE Adverse Event Report: STRYKER GMBH BIXCUT - IM REAMER, MOD. TRINKLE FITTING D9.0X480MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02276090
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during the tha surgery on (b)(6) 2025, a 9mm flexible reamer was used to ream the femoral medullary cavity.Due to the narrow medullary cavity, the reamer was used without a guide wire.Because of the narrow medullary cavity, stress was placed on the instrument during reaming, causing it to break (bend).No instrument parts remained inside the patient due to the breakage.The surgery concluded without issues, and we have been informed that no health complications have been reported to date.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned part was confirmed based on the catalog # and the lot # marked.The reamer is severely bent in the flexible part near the shaft.This led to severe overloading of the reamer and deformation.As no guide wire was used according to the report, the root cause was attributed to a user-related problem.Reference to this in: bixcut instructions for use l22000065 rev ab, 06-2022: 7 warnings and precautions: 7.2 intra-operative.Caution: "always perform intramedullary reaming over a k-wire to prevent the reamer from drifting uncontrollably." 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.
Event or Problem Description
As reported: "during the tha surgery on (b)(6) 2025, a 9mm flexible reamer was used to ream the femoral medullary cavity.Due to the narrow medullary cavity, the reamer was used without a guide wire.Because of the narrow medullary cavity, stress was placed on the instrument during reaming, causing it to break (bend).No instrument parts remained inside the patient due to the breakage.The surgery concluded without issues, and we have been informed that no health complications have been reported to date.".

• Brand Name: BIXCUT - IM REAMER, MOD. TRINKLE FITTING D9.0X480MM
• 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: 23706963
• Report Number: 0008031020-2025-02116
• Device Sequence Number: 10691707
• Product Code: LXH
• UDI-Device Identifier: 04546540145826
• UDI-Public: (01)04546540145826(10)K1D3383
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 02276090
• Device Lot Number: K1D3383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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: Male