MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 LOCKING, SHORT, Ø3.1 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	705031S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported, orif was performed for a patient with right tibia fracture.Drill was fractured during use, and tip of it was left in the bone.Thus, the surgeon made an additional incision and removed it from the bone on the opposite side.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned broken.The device inspection revealed the following: as received condition, the drill bit is broken off at the cross over from the cutting flutes to the shaft.The fragment was also returned.The received drill shows signs of usage.Strong fretting marks are visible.The drill bit lot number identification cannot be confirmed as the lot is rubbed off.The breakage surface reveals typical characteristics of a brittle fracture: the surface appears irregular and relatively smooth on certain areas, there is no noticeable signs of plastic deformations.Since the breakage was brittle (sudden) in nature, there is evidence of abrupt features especially by plateau on both sides of the fracture face.The most likely root cause is torsional overload caused by excessive force applied during use.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.Based on investigation, the root cause was attributed to a user related issue.The event was caused by torsional overload and excessive force applied to the device during use.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.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported, orif was performed for a patient with right tibia fracture.Drill was fractured during use, and tip of it was left in the bone.Thus, the surgeon made an additional incision and removed it from the bone on the opposite side.

• Brand Name: DRILL BIT AXSOS 3 LOCKING, SHORT, Ø3.1 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21095548
• Report Number: 0008031020-2025-00004
• Device Sequence Number: 21111671
• Product Code: HWE
• UDI-Device Identifier: 07613327083330
• UDI-Public: (01)07613327083330(10)5474AA
• 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): 02/25/2025

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: 705031S
• Device Lot Number: 5474AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown