MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 NON-LOCKING, SHORT, Ø2.5 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	705025S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tap tip broke off and could not be removed.The procedure was terminated with the tap tip remaining in the patient's bone.In same procedure, the drill bit was broken.All debris were removed from the patient.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.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 tap tip broke off and could not be removed.The procedure was terminated with the tap tip remaining in the patient's bone.In same procedure, the drill bit was broken.All debris were removed from the patient.
Additional Manufacturer Narrative
Correction to h6(device code).The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The received device shows signs of prior usage, as we can see heavy, scratch marks throughout the periphery of the device caused by usage over time.The breakage surface indicates breakage in a brittle manner caused by the application of excessive torsional force combined with axial movement.The fracture surface doesn¿t show any signs of plastic deformation and is shiny in nature.The outer diameter of drill was verified and was observed within specification.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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.Based on the above investigation, the root cause could be determined to be user-related as breakage is caused due to application of a combination of torsional and axial load.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL BIT AXSOS 3 NON-LOCKING, SHORT, Ø2.5 X 216MM
• 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: 22888978
• Report Number: 0008031020-2025-01425
• Device Sequence Number: 8790313
• Product Code: HWE
• UDI-Device Identifier: 07613327083439
• UDI-Public: (01)07613327083439(17)290731(10)5840AA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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
• Device Catalogue Number: 705025S
• Device Lot Number: 5840AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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: 61 YR
• Patient Sex: Male