MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SONOPET ANGLED HANDPIECE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	5450820000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2020
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: 4 events were reported for this quarter.Product return status: 2 devices were received.2 device investigation types have not yet been determined.Event confirmation status: 2 reported events were not confirmed.Evaluation results: 1 device was found to be affected by insulation resistance.1 device had no problem found.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 4 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.1 event 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: 4 previously reported events are included in this follow-up record.Product return status: 4 devices were received.
Event or Problem Description
This report summarizes 4 malfunction events in which the device reportedly overheated.- 3 events had no patient involvement; no patient impact.- 1 event had patient involvement; no patient impact.

• Brand Name: SONOPET ANGLED HANDPIECE, UNIVERSAL
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 10331393
• Report Number: 0008043928-2020-00010
• Device Sequence Number: 3451278
• Product Code: LFL
• UDI-Device Identifier: 07613327291919
• UDI-Public: 07613327291919
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: No Information
• Device Model Number: 5450820000
• Device Catalogue Number: 5450820000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1