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

Catalog Number	705025S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
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: "the tip of the 705025s drill (2.5 mm) broke off.The tipi of the drill was retrieved from inside the patient's bone.Backup devices had to be used.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged issue.The device inspection revealed the following: the received drill showed significant signs of usage evident by dull cutting edges of the flutes and scratch marks all over.However, the tip region was found to be broken just around the point where the cutting edges begin.The fracture surface exhibited mixed characteristics of a brittle & ductile failure evident by some plastic deformation and some smooth surface.Predominantly it appears to be a brittle one caused most likely due to excessive torsional & bending loading.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.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 breakage indicates towards an inappropriate usage of the screwdriver evident by a largely brittle fracture indicating towards application of excessive bending & torsional loading.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the tip of the 705025s drill (2.5 mm) broke off.The tipi of the drill was retrieved from inside the patient's bone.Backup devices had to be used.".

• Brand Name: DRILL BIT AXSOS 3 NON-LOCKING, SHORT, Ø2.5 X 216MM
• Common Device Name: INSTRUMENTAL, 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: 22822206
• Report Number: 0008031020-2025-01385
• Device Sequence Number: 9275231
• Product Code: HWE
• UDI-Device Identifier: 07613327083439
• UDI-Public: (01)07613327083439(17)291130(10)6070AA
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 705025S
• Device Lot Number: 6070AA
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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: 60 YR
• Patient Sex: Male