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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SABO2 SAG SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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SABO2 SAG SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 4408000000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/30/2021
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: 4 events were reported for this quarter.Product return status: 3 devices were received.1 device investigation type has not yet been determined.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed or reused.
 
Event or Problem Description
This report summarizes 4 malfunction events in which the device had a component detach.3 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
 
Event or Problem Description
This report summarizes 4 malfunction events in which the device had a component detach.3 events had no patient involvement; no patient impact.1 event 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: 4 previously reported events are included in this follow-up record.Product return status: 4 devices were received.
 
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Brand Name
SABO2 SAG SAW
Common Device Name
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
MDR Report Key12203644
Report Number3015967359-2021-01539
Device Sequence Number4371244
Product Code HWE
UDI-Device Identifier07613252481478
UDI-Public07613252481478
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized4
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) 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
Operator of Device No Information
Device Model Number4408000000
Device Catalogue Number4408000000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/30/2021
Supplement Date Received by Manufacturer06/30/2021
Initial Report FDA Received Date07/21/2021
Supplement Report FDA Received Date10/26/2021
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 Number1
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