MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 3.0MM DIAMOND MATCH HEAD, DISTAL BEND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8431107030D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting for device return to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, two burs broke during use.It was also reported the event caused a 90 minute delay to the procedure.It was further reported that there was no adverse consequences and no medical intervention as a result of this event.It was further reported that the procedure was completed successfully.This record addresses the second instance of the bur break which was reported.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, two burs broke during use.It was also reported the event caused a 90 minute delay to the procedure.It was further reported that there was no adverse consequences and no medical intervention as a result of this event.It was further reported that the procedure was completed successfully.This record addresses the second instance of the bur break which was reported.

• Brand Name: 3.0MM DIAMOND MATCH HEAD, DISTAL BEND
• 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: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18192599
• Report Number: 3015967359-2023-02504
• Device Sequence Number: 20644684
• Product Code: HBE
• UDI-Device Identifier: 07613327509229
• UDI-Public: 07613327509229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210377
• 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,Followup
• Report Date (Section B): 05/07/2024

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: 8431107030D
• Device Lot Number: 22180017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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