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	11/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, the tip of the device broke.It was also reported there were no delays, no adverse consequences and no medical intervention as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : product status unknown.
Event or Problem Description
It was reported that during a surgical procedure, the tip of the device broke.It was also reported there were no delays, no adverse consequences and no medical intervention 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-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: 15904101
• Report Number: 3015967359-2022-02375
• Device Sequence Number: 12270752
• Product Code: LFL
• UDI-Device Identifier: 37613252518403
• UDI-Public: 37613252518403
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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 Catalogue Number: 5450-815-114
• Device Lot Number: 1000494835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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