MAUDE Adverse Event Report: STRYKER MEDTECH SONOPET ANGLED HANDPIECE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	5450820000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
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: 10 events were reported for this quarter.Product return status: 9 devices were received.1 device was not available for evaluation.Event confirmation status: 9 reported events were not confirmed.Evaluation results: 1 device was found to be affected by a misaligned angle nut.8 devices had no problem found.Additional information: 9 devices were not labeled for single-use.9 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 10 malfunction events in which the device reportedly overheated.8 events had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.

• Brand Name: SONOPET ANGLED HANDPIECE, UNIVERSAL
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER MEDTECH; 1131-1 higashi naganuma; inagi 206-0 802; JA 206-0802
• MDR Report Key: 10748086
• Report Number: 0008043928-2020-00016
• Device Sequence Number: 14462787
• 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: 10
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1