MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 5.0MM COARSE DIAMOND ROUND, DISTAL BEND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	8431-013-050DC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3: awaiting for device return to manufacturer.
Event or Problem Description
Per medwatch report#; mw5117493; it was reported that during a surgical procedure, the bur broke.It was also reported there were no delays, no adverse consequences and no medical intervention as a result of this event.It was further reported that all pieces of the broken bur were retrieved successfully.It was also reported that the procedure was completed successfully.
Event or Problem Description
Per medwatch report#; mw5117493; it was reported that during a surgical procedure, the bur broke.It was also reported there were no delays, no adverse consequences and no medical intervention as a result of this event.It was further reported that all pieces of the broken bur were retrieved successfully.It was also reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text: product status unknown.

• Brand Name: 5.0MM COARSE DIAMOND ROUND, 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: 17134154
• Report Number: 3015967359-2023-01308
• Device Sequence Number: 17754500
• Product Code: HBE
• UDI-Device Identifier: 07613327501186
• UDI-Public: 07613327501186
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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 Model Number: 8431-013-050DC
• Device Catalogue Number: 8431013050DC
• Device Lot Number: 22224017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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