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

Catalog Number	8431013050DC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per medwatch report#: mw5145184; it was reported that during a surgical procedure, the bur broke.It was also reported the event caused an unknown serious injury.No further information was provided.
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
Per medwatch report#: mw5145184; it was reported that during a surgical procedure, the bur broke.It was also reported the event caused an unknown serious injury.No further information was provided.
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: 17894147
• Report Number: 3015967359-2023-02079
• Device Sequence Number: 2491497
• 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): 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8431013050DC
• Device Lot Number: 23157017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 02/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown