MAUDE Adverse Event Report: STRYKER GMBH BIXCUT - IM REAMER, AO FITTING D8.5X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02256085
Medical Device Problem Codes	Break (1069); Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
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
The customer reported that "59-year-old patient treated for an open fracture of both bones of the right leg following an avp.During the operation (osteosynthesis by centromedullary nailing), an 8.5-diameter reamer broke inside the patient and became stuck on the guide rod.The material was able to be recovered by the surgeon.Increased operating time.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The return was visually inspected, revealing that the device is broken into two fragments at the distal end, and the other fragment was not returned for inspection.The microscopic view of the broken section indicates that the device was shattered in a brittle manner by applying high torsional overload.The breakage surface is shiny in nature, with no plastic deformation.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 can be attributed to the user-related as breakage was caused by application of high torsional force.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that "59-year-old patient treated for an open fracture of both bones of the right leg following an avp.During the operation (osteosynthesis by centromedullary nailing), an 8.5-diameter reamer broke inside the patient and became stuck on the guide rod.The material was able to be recovered by the surgeon.Increased operating time.".

• Brand Name: BIXCUT - IM REAMER, AO FITTING D8.5X480 MM
• 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: 22649477
• Report Number: 0008031020-2025-01309
• Device Sequence Number: 8823445
• Product Code: LXH
• UDI-Device Identifier: 04546540145345
• UDI-Public: (01)04546540145345(10)K076DCD
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 02256085
• Device Lot Number: K076DCD
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• 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: 59 YR
• Patient Sex: Male