MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.5MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820103015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned.
Event or Problem Description
It was reported that during a craniotomy surgical procedure, the drill broke.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was delayed by 05 minutes and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 : device discarded.
Event or Problem Description
It was reported that during a craniotomy surgical procedure, the drill broke.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was delayed by 05 minutes and the procedure was completed successfully.

• Brand Name: 1.5MM WIRE PASS DRILL BIT
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11424143
• Report Number: 3015967359-2021-00061
• Device Sequence Number: 3243537
• Product Code: HBE
• UDI-Device Identifier: 04546540362421
• UDI-Public: 04546540362421
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: 5820103015
• Device Catalogue Number: 5820103015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1