MAUDE Adverse Event Report: STRYKER GMBH BIXCUT - IM REAMER, MOD. TRINKLE FITTING D8.5X480MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02276085
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
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: "shaft damage of the reamer shaft.".
Additional Manufacturer Narrative
Correction: please refer to section h6 (device code).The reported event could be confirmed, since evaluation revealed a damaged reamer spiral.The shaft shows deformation and open spiral at the beginning of the flexible part in the area of transition from the adapter part to the flexible scraper shaft.The labelling clearly points out.Always treat the instrument carefully to avoid surface damage or alterations to the geometry.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.Since nothing was reported during pre-operative check or after last surgery resp.Reprocessing and /or maintenance and based on signs of damage found it could not be excluded that the event reported is rather linked to improper handling during procedure.In case of intended use such damage would not have occurred.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "shaft damage of the reamer shaft.".

• Brand Name: BIXCUT - IM REAMER, MOD. TRINKLE FITTING D8.5X480MM
• 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: 22877655
• Report Number: 0008031020-2025-01411
• Device Sequence Number: 12184515
• Product Code: LXH
• UDI-Device Identifier: 04546540145819
• UDI-Public: (01)04546540145819(10)K0FD9A5
• 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): 12/23/2025

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: 02276085
• Device Lot Number: K0FD9A5
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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: 52 YR
• Patient Sex: Male