MAUDE Adverse Event Report: STRYKER GMBH CALIBRATED DRILL BIT Ø2.5MM X 285MM, AO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	703586
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/24/2019
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.Remainder of device was discarded.
Event or Problem Description
It was reported that during a left tibial plateau procedure, a drill bit broke approximately halfway through.A second drill bit was used and also broke approximately halfway through.The broken portion of the bits in the patient's bone were left in.The targeter had to be removed and the procedure continued percutaneously without the targeter.Surgery was completed successfully with a delay of approximately 35 to 40 minutes.Surgeon reported patient's bone quality as average.

• Brand Name: CALIBRATED DRILL BIT Ø2.5MM X 285MM, 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: 9604537
• Report Number: 0008031020-2020-00109
• Device Sequence Number: 11574216
• Product Code: HWE
• UDI-Device Identifier: 04546540694089
• UDI-Public: 04546540694089
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/17/2020

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 Catalogue Number: 703586
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1