MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 12CM IQ MICRO CLAW; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B315
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a jawbone osteotomy, a patient had a burn injury on the mouth corner.An antibiotic ointment was prescribed to treat the burn by keeping the area moist.The burn will not need additional treatment and no infection was observed.The procedure was completed successfully without a delay.No medical intervention was reported.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a jawbone osteotomy, a patient had a burn injury on the mouth corner.An antibiotic ointment was prescribed to treat the burn by keeping the area moist.The burn will not need additional treatment and no infection was observed.The procedure was completed successfully without a delay; no medical intervention was reported.
Additional Manufacturer Narrative
Second degree burn.The quality investigation is complete.

• Brand Name: 12CM IQ MICRO CLAW
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• 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: 16625938
• Report Number: 3015967359-2023-00613
• Device Sequence Number: 4457783
• Product Code: LFL
• UDI-Device Identifier: 37613327422383
• UDI-Public: 37613327422383
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213824
• 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): 06/22/2023

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: 01/01/2024
• Device Catalogue Number: 550025B315
• Device Lot Number: 21356027
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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
• Patient Sex: Male