MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI LOCKING, MEDIUM, Ø3.1 X 238MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	705077
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient was admitted for a tibial plateau osteosynthesis procedure.During one of the drilling operations, the tip of the drill bit broke off inside the bone and became lodged in the tibia.The drill bit remained in the patient.
Event or Problem Description
It was reported that the patient was admitted for a tibial plateau osteosynthesis procedure.During one of the drilling operations, the tip of the drill bit broke off inside the bone and became lodged in the tibia.The drill bit remained in the patient.
Additional Manufacturer Narrative
Please note the correction to d9.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.It was reported that questions were raised regarding the lifespan of the drill bit and the number of uses.In this relation, it can be pointed out that the stryker instructions for cleaning, sterilization, inspection and maintenance provides information to identify when the device should no longer be reused or is still within specification.When cleaned, sterilized and maintained according to the instructions provided within this document and documents referenced therein, the reusable medical devices maintain their function and biocompatibility over the lifetime of the device.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL BIT AXSOS 3 TI LOCKING, MEDIUM, Ø3.1 X 238MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23636031
• Report Number: 0008031020-2025-02099
• Device Sequence Number: 9317579
• Product Code: HWE
• UDI-Device Identifier: 07613327083361
• UDI-Public: 07613327083361
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 705077
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown