MAUDE Adverse Event Report: SYSTEM 8 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 8208000000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2021

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 2 events were reported for this quarter.Product return status 2 device investigation types have not yet been determined.Additional information 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.

Event Description

This report summarizes 2 malfunction events in which the device was reportedly leaking.- 2 events had no 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: 2 previously reported events are included in this follow-up record.Product return status: 2 devices were received.

Event Description

This report summarizes 2 malfunction events in which the device was reportedly leaking.2 events had no patient involvement; no patient impact.

• Brand Name: SYSTEM 8 SAGITTAL SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• MDR Report Key: 12203805
• MDR Text Key: 262706470
• Report Number: 3015967359-2021-01581
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327304541
• UDI-Public: 07613327304541
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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
• Device Operator: No Information
• Device Model Number: 8208000000
• Device Catalogue Number: 8208000000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1