MAUDE Adverse Event Report: STRYKER GMBH BIXCUT - IM REAMER, MOD. TRINKLE FITTING D7.5X480MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02276075
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "orif for distal humerus fracture (t2 humerus nail) during medullary cavity reaming with a big cut reamer, the base of the 7.5 mm reamer shaft fractured.The physician thought the break occurred due to strong resistance from the narrow medullary cavity and hard bone in this young male patient, which placed stress on the reamer's base.No fragments remained inside the patient, and the procedure was completed without further issues.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "orif for distal humerus fracture (t2 humerus nail) during medullary cavity reaming with a big cut reamer, the base of the 7.5 mm reamer shaft fractured.The physician thought the break occurred due to strong resistance from the narrow medullary cavity and hard bone in this young male patient, which placed stress on the reamer's base.No fragments remained inside the patient, and the procedure was completed without further issues.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device is broken as described in the event description.The device inspection revealed the following: the reported reamer was returned for evaluation.It can be confirmed that the reamer is broken apart at the crossover from the flexible shaft to the coupling piece.The complete coupling piece was not returned for evaluation.At the flexible shaft are slight stress marks and some deformations visible.The cutting edges of the reamer are slightly worn but in general in acceptable condition.The breakage surfaces show no plastic deformation and identify a brittle overload fracture.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.No product related issue could be detected.The complete coupling piece was not returned, which make a full investigation and the determination of a exact root cause impossible.Most likely did a mechanical overload by the reported strong resistance from the narrow medullary cavity and hard bone lead to the breakage of the device.If more information is provided, the case will be reassessed.

• Brand Name: BIXCUT - IM REAMER, MOD. TRINKLE FITTING D7.5X480MM
• 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: 23368679
• Report Number: 0008031020-2025-01989
• Device Sequence Number: 8916247
• Product Code: LXH
• UDI-Device Identifier: 04546540145796
• UDI-Public: (01)04546540145796(11)210505(10)K0CD7D0
• 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): 02/10/2026

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: 02276075
• Device Lot Number: K0CD7D0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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: 28 YR
• Patient Sex: Male