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

Model Number 1900034000

Device Problem Overheating of Device (1437)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 12 events were reported for this quarter.Product return status: 6 devices were received.6 device investigation types have not yet been determined.Event confirmation status: 5 reported events were confirmed.1 reported event was not confirmed.Evaluation results: 4 devices were found to be affected by a damaged bearing.1 device was found to be affected by a damaged rotor.1 device had no problem found.12 devices were not labeled for single-use.12 devices were not reprocessed or reused.

Event Description

This report summarizes 12 malfunction events in which the device reportedly overheated.11 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.

Event Description

This report summarizes 12 malfunction events in which the device reportedly overheated.- 7 events had no patient involvement; no patient impact.- 5 events had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 12 previously reported events are included in this follow-up record.Product return status: 9 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status: 5 reported events were confirmed.4 reported events were not confirmed.Evaluation results: 4 devices were found to be affected by a damaged bearing.1 device was found to be affected by a damaged rotor.4 devices had no problem found.

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 12 previously reported events are included in this follow-up record.Product return status 9 devices were received.3 devices were not available for evaluation.

Event Description

This report summarizes 12 malfunction events in which the device reportedly overheated.- 7 events had no patient involvement; no patient impact.- 5 events had patient involvement; no patient impact.

• Brand Name: F1 SAG SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9997321
• MDR Text Key: 190530180
• Report Number: 0001811755-2020-01122
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327072006
• UDI-Public: 07613327072006
• Combination Product (y/n): N
• Number of Events Reported: 12
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1900034000
• Device Catalogue Number: 1900034000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1