MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SONIC CONTROL SERRATED AGGRESSIVE KNIFE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450815114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting information if device is available for return.
Event or Problem Description
It was reported that prior to a surgical procedure, the tip of the device broke during device assembly.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.
Additional Manufacturer Narrative
H6; upon evaluating the associated handpiece (under pr 2514996 sonopet angled handpiece, universal 5450820000 sn (b)(6)), it was identified that overtorquing of the tip onto the handpiece occured during set up, as a result the angle/tip joint had sheared off, however, the tip was fully intact.As as result, the tip is deemed concomitant.If new information becomes available, this will be re-assessed.H3 other text : device discarded by customer.
Event or Problem Description
It was reported that prior to a surgical procedure, the tip of the device broke broke during device assembly.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.

• Brand Name: SONIC CONTROL SERRATED AGGRESSIVE KNIFE, UNIVERSAL
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10707892
• Report Number: 0001811755-2020-02753
• Device Sequence Number: 11475360
• Product Code: LFL
• UDI-Device Identifier: 37613252518403
• UDI-Public: 37613252518403
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K020220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 5450815114
• Device Lot Number: 1000377558
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1