MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP F1 SAG SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	1900034000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2023
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 8 events were reported for this quarter.Product return status 5 devices were received.3 device investigation types have not yet been determined.Additional information 8 devices were not labeled for single-use.8 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 8 malfunction events in which the device reportedly overheated.- 3 events had no patient involvement; no patient impact.- 4 events had patient involvement; no patient impact.- 1 event had insufficient information received.
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: h6, h11 8 previously reported events are included in this follow-up record.Product return status 7 devices were received.1 device was not available for evaluation.
Event or Problem Description
This report summarizes 8 malfunction events in which the device reportedly overheated.- 3 events had no patient involvement; no patient impact.- 5 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: b5, h6, h10 8 previously reported events are included in this follow-up record.Product return status 6 devices were received.2 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 8 malfunction events in which the device reportedly overheated.- 3 events had no patient involvement; no patient impact.- 5 events had patient involvement; no patient impact.

• Brand Name: F1 SAG SAW
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18557722
• Report Number: 3015967359-2024-00296
• Device Sequence Number: 7699864
• Product Code: HWE
• UDI-Device Identifier: 07613327072006
• UDI-Public: 07613327072006
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 8
• 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): 04/17/2024

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 Catalogue Number: 1900034000
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/31/2023; 12/31/2023
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 01/26/2024; 04/18/2024
• 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