MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2.5MM DIAMOND MATCH HEAD, PROXIMAL BEND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8442107025D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
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 confirmation if the device is available.
Event or Problem Description
It was reported that during a procedure the head of the bur broke off.The procedure was completed successfully, without a clinically significant delay; no medical intervention was reported.No further information was reported.
Event or Problem Description
It was reported that during a procedure the head of the bur broke off.The procedure was completed successfully, without a clinically significant delay; no medical intervention was reported.No further information was reported.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: 2.5MM 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: 18489622
• Report Number: 3015967359-2024-00036
• Device Sequence Number: 20597283
• Product Code: HBE
• UDI-Device Identifier: 07613327500813
• UDI-Public: 07613327500813
• 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): 06/04/2024

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 Expiration Date: 05/01/2024
• Device Catalogue Number: 8442107025D
• Device Lot Number: 22137017
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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