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	06/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device evaluated by mfr: awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the tip broke on three devices within the same procedure.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.This record addresses one of the reported instances of the tip breaking.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the tip broke on three devices within the same procedure.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.This record addresses one of the reported instances of the tip breaking.

• 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-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 14982010
• Report Number: 3015967359-2022-01282
• Device Sequence Number: 5099091
• Product Code: LFL
• UDI-Device Identifier: 37613252518403
• UDI-Public: 37613252518403
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K020220
• 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): 10/04/2022

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 Catalogue Number: 5450-815-114
• Device Lot Number: 1000403743
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 10/04/2022
• 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
• Patient Sex: Unknown