MAUDE Adverse Event Report: STRYKER GMBH CALIBRATED DRILL BIT 4.3MM X 315MM, AO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	703541
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/07/2020
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 was discarded.
Event or Problem Description
As reported: "tip of axsos3 4.3mm drill (item no.703541) broke off inside left distal femur whilst drilling the bone in preparation for screw insertion.Approximately 10mm of 4.3mm drill bit retained.Position of broken drill tip inside bone confirmed by x-ray.Patient informed post op.".

• Brand Name: CALIBRATED DRILL BIT 4.3MM X 315MM, AO
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10485732
• Report Number: 0008031020-2020-02209
• Device Sequence Number: 19509868
• Product Code: HWE
• UDI-Device Identifier: 04546540693792
• UDI-Public: 04546540693792
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: 703541
• Device Catalogue Number: 703541
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1