MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM CRSE DMND MTCH HD, 16CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	8470107040DC
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during a surgical procedure, the bur and the attachment were contacted and a spark was observed.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Corrected data: h3: it was initially reported that the bur was discarded, it was subsequently reported that the bur was discarded after it was evaluated.Additional narrative: h6: investigation results indicate that damaged bearing with the associated attachment (5407120970c sn unknown) contributed to this event.The quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the bur and the attachment were contacted and a spark was observed.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

• Brand Name: 4.0MM CRSE DMND MTCH HD, 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: 16492080
• Report Number: 3015967359-2023-00517
• Device Sequence Number: 20467137
• Product Code: HBE
• UDI-Device Identifier: 07613327097283
• UDI-Public: 07613327097283
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/20/2023

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: 8470107040DC
• Device Catalogue Number: 8470107040DC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5407120970C SN UNKNOWN
• Patient Sex: Unknown