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	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was discarded by the customer.
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the knife tip broke off in the patient's bone.The user facility reported that the procedure was completed successfully without a delay, and that there were no adverse consequences or medical intervention.

• 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: 7694622
• Report Number: 0001811755-2018-01167
• Device Sequence Number: 19044636
• Product Code: LFL
• UDI-Device Identifier: 37613252518380
• UDI-Public: 37613252518380
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 07/17/2018

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: No Information
• Device Catalogue Number: 5450815107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1