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

Catalog Number	5450815114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 3 events were reported for this quarter.Product return status: 3 device investigation types have not yet been determined.Additional information: 3 devices were labeled for single-use.3 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device had a broken cutting accessory still attached.3 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale 3 previously reported events are included in this follow-up record.Product return status 1 devices were received.1 devices were not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status 1 reported events were confirmed.Evaluation results 1 device was found to be affected by a worn component.
Event or Problem Description
This report summarizes 3 malfunction events in which the device had a broken cutting accessory still attached.3 events had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 3 malfunction events in which the device had a broken cutting accessory still attached.3 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: 3 previously reported events are included in this follow-up record.Product return status 2 devices were received.1 devices were not available for evaluation.Event confirmation status 2 reported events were confirmed.Evaluation results 1 device was found to be affected by wear.1 device was found to be affected by a broken tip.

• 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: 8546058
• Report Number: 0001811755-2019-01386
• Device Sequence Number: 16236544
• Product Code: LFL
• UDI-Device Identifier: 37613252518403
• UDI-Public: 37613252518403
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2019

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: No Information
• Device Catalogue Number: 5450815114
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2019
• Supplement Date Received by Manufacturer: 01/01/2019; 01/01/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/26/2019; 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1