MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM COARSE DIAMOND ROUND, 16CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	8470012040DC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available for return.
Event or Problem Description
It was reported via the customer that during a surgical procedure, the bur broke in the attachment.It was also reported that there was a ten minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported via the customer that during a surgical procedure, the bur broke in the attachment.It was also reported that there was a ten minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Event or Problem Description
It was reported via the customer that during a surgical procedure, the bur broke in the attachment.It was also reported that there was a ten minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
D4: the lot number reported initially was 1926017, the corrected lot number is 19262017.

• Brand Name: 4.0MM COARSE DIAMOND ROUND, 16CM
• 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: 12853495
• Report Number: 3015967359-2021-02608
• Device Sequence Number: 20104209
• Product Code: HBE
• UDI-Device Identifier: 07613327096941
• UDI-Public: 07613327096941
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K143540
• 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,Followup
• Report Date (Section B): 02/25/2022

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: 8470012040DC
• Device Catalogue Number: 8470012040DC
• Device Lot Number: 19262017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 01/27/2022; 02/24/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/28/2022; 02/25/2022
• 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