MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP FLYTE BATTERY POWERED LIGHTED HELMET; HELMET, SURGICAL

Model Number	0408645000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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: 2 events were reported for this quarter.Product return status: 2 device investigation types have not yet been determined.2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device reportedly overheated.2 events had no 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: 2 previously reported events are included in this follow-up record.Product return status: 2 devices were received.
Event or Problem Description
This report summarizes 2 malfunction events in which the device reportedly overheated.- 2 events had patient involvement; no patient impact.

• Brand Name: FLYTE BATTERY POWERED LIGHTED HELMET
• Common Device Name: HELMET, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11728534
• Report Number: 3015967359-2021-00547
• Device Sequence Number: 19587644
• Product Code: FXZ
• UDI-Device Identifier: 04546540591609
• UDI-Public: 04546540591609
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• 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): 07/29/2021

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: 0408645000
• Device Catalogue Number: 0408645000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2021
• Supplement Date Received by Manufacturer: 01/01/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1