MAUDE Adverse Event Report: STRYKER GMBH BIXCUT - IM REAMER, MOD. TRINKLE FITTING D8.0X480MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02276080
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
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: "after removal of the mrs stem, a reamer was used to remove cement, the reamers broke.No broken pieces were generated, and the shaft of the reamer was stretched.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device is deformed as described in the event description.The device inspection revealed the following: two bixcut reamers were returned for evaluation.The reported catalog- and lot numbers could be confirmed based on the laser markings on the devices.The visual inspection has shown that both devices are strongly deformed at the flexible shaft.The evaluation has also shown that both devices are in a very used condition.There are many nicks and dents at the couplings and as well at the cutting edges visible.The damages indicate that the devices were previously used without any issues.A review of the device history for the reported lot did not indicate any abnormalities.The device was manufactured in the year 2020 with a lot size of 30 pieces and we are not aware of any other complaint for the affected lot.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 investigation, the root cause was attributed to a user related issue.The event was caused by inappropriate handling; such a strong deformation of the flexible shaft is normally only possible when the device is used without the guidance of a guidewire.This is also indicated by the fact that the guide wire is not stuck in the device, because in the received condition a removal of a guide wire would have been impossible.Next to that were the devices used to remove cement after a stem removal, so it is possible that much higher reaming forces were required compared to normal bone, especially when the cement was not applied evenly.Finally wear and tear might also have played a role, as both reamer heads were partially blunt, which did also lead to a increased reaming force.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "after removal of the mrs stem, a reamer was used to remove cement, the reamers broke.No broken pieces were generated, and the shaft of the reamer was stretched.".

• Brand Name: BIXCUT - IM REAMER, MOD. TRINKLE FITTING D8.0X480MM
• 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: 23263715
• Report Number: 0008031020-2025-01683
• Device Sequence Number: 17438071
• Product Code: LXH
• UDI-Device Identifier: 04546540145802
• UDI-Public: (01)04546540145802(11)201105(10)K02FCE7
• 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): 01/20/2026

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: 02276080
• Device Lot Number: K02FCE7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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