MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 3.5MM DMND MTCH HEAD, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	8450107035D
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device heated up during an endoscopic endonasal case, resulting in a minor first degree burn to the inside of the patient's nostril.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation if device is available for return.
Event or Problem Description
It was reported that the device heated up during an endoscopic endonasal case, resulting in a minor first degree burn to the inside of the patient's nostril.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
D4: lot number updated from unknown to 21246017.H6: the quality investigation is complete.H3 other text: device not returned.

• Brand Name: 3.5MM DMND MTCH HEAD, 13CM
• 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: 16817924
• Report Number: 3015967359-2023-01033
• Device Sequence Number: 20614165
• Product Code: HBE
• UDI-Device Identifier: 07613327097078
• UDI-Public: 07613327097078
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K143540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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 Expiration Date: 09/01/2026
• Device Model Number: 8450107035D
• Device Catalogue Number: 8450107035D
• Device Lot Number: 21246017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2021
• 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: 5407120900,MIS HUB, SN (B)(6); 5407120950C,MIS 13CM CURVED ATTACH, SN (B)(6); 5407120970C,MIS 16CM CURVED ATTACH, SN (B)(6); 5407300000,PI DRIVE PLUS MOTOR, SN UNKNOWN
• Patient Sex: Unknown