MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM FINE DIAMOND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820012040
Medical Device Problem Codes	Flaked (1246); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lumber surgical procedure, the bur broke, the procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available for return.
Additional Manufacturer Narrative
B5: it was initially reported, that the bur broke.Upon evaluation, the diamond grit fragments fell off the head of the bur.H6: the quality investigation is complete.
Event or Problem Description
It was reported, that during, a lumber surgical procedure.The bur broke.The procedure was completed successfully without a delay.No adverse consequences or medical intervention were reported.It was further reported, that following evaluation of the returned bur, it not break.The diamond grit fragments fell off the head of the bur.

• Brand Name: 4.0MM FINE DIAMOND
• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16018636
• Report Number: 3015967359-2022-02467
• Device Sequence Number: 12188882
• Product Code: HBE
• UDI-Device Identifier: 04546540346520
• UDI-Public: 04546540346520
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143320
• 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): 02/20/2023

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: 5820012040
• Device Catalogue Number: 5820012040
• Device Lot Number: 22214027
• 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: 12/01/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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