MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, 2.5 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	705025
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
As reported: "i was notified by a physician that a drill bit broke inside the patient's bone during an orif tibia plateau at memorial hermann the woodlands on monday (b)(6) 2020.Surgeon was drilling the most distal hole of the plate at an angle, and the drill bit broke off in the far cortex.A screw was then inserted just proximal to where the tip of the drill was left.".

• Brand Name: DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, 2.5 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
• MDR Report Key: 10962728
• Report Number: 0008031020-2020-02551
• Device Sequence Number: 3211137
• Product Code: HWE
• UDI-Device Identifier: 07613327083422
• UDI-Public: 07613327083422
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 12/07/2020

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 Model Number: 705025
• Device Catalogue Number: 705025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR