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	12/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 3 malfunction events in which the device reportedly overheated.2 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.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 not labeled for single-use.3 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 5 malfunction events in which the device reportedly overheated.4 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: corrected data: b5, h1, h6, h10.3 events were originally reported for this failure mode during the reporting quarter; however, 2 events were inadvertently excluded.5 reported events are included in this follow-up record.Product return status: 1 device was received.4 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 5 malfunction events in which the device reportedly overheated.4 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: corrected data: h10; 5 previously reported events are included in this follow-up record.Product return status: 5 devices were received.

• Brand Name: SONOPET ANGLED HANDPIECE, UNIVERSAL
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER MEDTECH; 1131-1 higashi naganuma; inagi MI 206-0 802; JA 206-0802
• Manufacturer (Section G): STRYKER MEDTECH; 1131-1 higashi naganuma; inagi MI 206-0 802; JA 206-0802
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13289810
• Report Number: 0008043928-2022-00001
• Device Sequence Number: 14591270
• 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: 5
• 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): 07/26/2022

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
• Device Model Number: 5450820000
• Device Catalogue Number: 5450820000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2021
• Supplement Date Received by Manufacturer: 12/31/2021; 12/31/2021
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 01/25/2022; 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown