MAUDE Adverse Event Report: STRYKER GMBH BIXCUT - IM REAMER, AO FITTING D11.0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02256110
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
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
It was reported that a reamer was damaged during use.It occurred during a procedure, but the surgeon was able to complete the procedure with 30 minutes delay due to failure to prepare the patient.
Additional Manufacturer Narrative
Correction: please refer to section h6 (device 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: the received reamer showed severe deformation and unravelling of the spiral portion across its length, while being significantly bent at one-third of its length.The cutting edges of the reamer were slightly worn off as well.The nature of deformation indicates most likely towards counter-clockwise rotation of the reamer during use, including extraction of it under immense force leading elongation of spiral at certain sections.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the issue is deemed to be user related.The nature of damage & deformation indicate towards an inappropriate use during the surgery involving rotation of the reamer in a counterclockwise direction.The operative technique indicates: reaming is commenced with the flexible shaft equipped with a small size reamer head.Continue the procedure in 0.5mm increments until cortical contact is appreciated.The ifu instructs the user that: 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.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a reamer was damaged during use.It occurred during a procedure, but the surgeon was able to complete the procedure with 30 minutes delay due to failure to prepare the patient.

• Brand Name: BIXCUT - IM REAMER, AO FITTING D11.0X480 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: 22843527
• Report Number: 0008031020-2025-01399
• Device Sequence Number: 4822936
• Product Code: LXH
• UDI-Device Identifier: 04546540145390
• UDI-Public: (01)04546540145390(10)K1123E5
• 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): 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: 02256110
• Device Lot Number: K1123E5
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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 Sex: Unknown