MAUDE Adverse Event Report: SABO2 SAG SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 4408000000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/30/2021

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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event in which the device was reportedly leaking.1 event 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 corrected data: b5, h1, h10.1 event was originally reported for this failure mode during the reporting quarter; however, - 1 event was inadvertently excluded.- 2 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: SABO2 SAG SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• MDR Report Key: 12680257
• MDR Text Key: 277967157
• Report Number: 3015967359-2021-02314
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613252481478
• UDI-Public: 07613252481478
• 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: 10/28/2021

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: 4408000000
• Device Catalogue Number: 4408000000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/28/2021
• 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