MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SONIC CONTROL SERRATED AGGRESSIVE KNIFE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450-815-114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
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 procedure, the tip of the sonopet knife broke.It was also reported that there were no adverse consequences to the patient or user as a result of this event.
Additional Manufacturer Narrative
The quality investigation is complete.
Event or Problem Description
It was reported that during a spinal surgery procedure, the tip of the sonopet knife broke.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: SONIC CONTROL SERRATED AGGRESSIVE KNIFE, UNIVERSAL
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• 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 D-791 11; EI D-79111
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 14993551
• Report Number: 3015967359-2022-01290
• Device Sequence Number: 19235909
• Product Code: LFL
• UDI-Device Identifier: 37613252518403
• UDI-Public: 37613252518403
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K020220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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 Expiration Date: 03/01/2023
• Device Catalogue Number: 5450-815-114
• Device Lot Number: 1000395452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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