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

Catalog Number	5450815107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device evaluated by manufacturer? awaiting device return.
Event or Problem Description
It was reported that the tip of the knife broke off during a procedure.It was also reported that the broken tip had to be retrieved and another device was used to complete the surgery.It was also reported that 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
Procedure was a spinal surgery the device was not returned for investigation.The quality investigation is complete.Device was not returned.
Event or Problem Description
It was reported that the tip of the knife broke off during a procedure.It was also reported that the broken tip had to be retrieved and another device was used to complete the surgery.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.It was also reported that it was a spinal case.

• Brand Name: SONIC CONTROL SERRATED KNIFE, UNIVERSAL
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8680331
• Report Number: 0001811755-2019-01918
• Device Sequence Number: 13957340
• Product Code: LFL
• UDI-Device Identifier: 37613252518380
• UDI-Public: 37613252518380
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K010637
• 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): 09/30/2019

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: 12/01/2021
• Device Catalogue Number: 5450815107
• Device Lot Number: M0020767
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1