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

Catalog Number	8442107030D
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
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, the head of the bur broke.It was also reported that the event contributed to a 10 minute delay.It was further reported that no medical intervention occurred.No further information was provided.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
B5; no adverse consequences were reported.H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the head of the bur broke.It was also reported that the event contributed to a 10 minute delay.It was further reported that no medical intervention and no adverse consequences occurred.It was further reported that the procedure was completed successfully.

• Brand Name: 3.0MM DIAMOND MATCH HEAD, PROXIMAL 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: 18703130
• Report Number: 3015967359-2024-00385
• Device Sequence Number: 7217555
• Product Code: HBE
• UDI-Device Identifier: 07613327500806
• UDI-Public: 07613327500806
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/10/2024

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: 8442107030D
• Device Lot Number: 22216017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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