MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.0MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820103010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
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 via medwatch report 0700220000-2023-8011 that the wire pass drill bit broke in half during a surgical procedure, all pieces were accounted for and retrieved, an x-ray was needed at the end of the case.The procedure was completed successfully; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported via medwatch report 0700220000-2023-8011 that the wire pass drill bit broke in half during a surgical procedure, all pieces were accounted for and retrieved, an x-ray was needed at the end of the case.The procedure was completed successfully; no adverse consequences or medical intervention were reported.

• Brand Name: 1.0MM 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16370776
• Report Number: 3015967359-2023-00412
• Device Sequence Number: 20536659
• Product Code: HBE
• UDI-Device Identifier: 04546540362407
• UDI-Public: 04546540362407
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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 Expiration Date: 10/01/2024
• Device Model Number: 5820103010
• Device Catalogue Number: 5820103010
• Device Lot Number: 21273017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown