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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP TPS XL OSCILLIATING SAW; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP TPS XL OSCILLIATING SAW; UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100131000
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 01/01/2021
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: 3 events were reported for this quarter.Product return status: 3 devices were received.Additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed or reused.
 
Event or Problem Description
This report summarizes 3 malfunction events in which the device had a component detach.3 events had no patient involvement; no patient impact.
 
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Brand Name
TPS XL OSCILLIATING SAW
Common Device Name
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11728532
Report Number3015967359-2021-00542
Device Sequence Number3018159
Product Code EIA
UDI-Device Identifier04546540983930
UDI-Public04546540983930
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized3
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/26/2021
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 Number5100131000
Device Catalogue Number5100131000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/01/2021
Initial Report FDA Received Date04/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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