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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS XL OSCILLIATING SAW; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO TPS XL OSCILLIATING SAW; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100131000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/24/2019
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: 5 events were reported for this quarter.Product return status: 4 devices were received.1 device was not available for evaluation.Event confirmation status: 4 reported events were confirmed.Evaluation results: 4 devices were found to be affected by a missing component.Additional information: 5 devices were not labeled for single-use.5 devices were not reprocessed and reused.
 
Event or Problem Description
This report summarizes 5 malfunction events in which the device had a component detach.5 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-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8816401
Report Number0001811755-2019-02476
Device Sequence Number3109743
Product Code EIA
UDI-Device Identifier04546540983930
UDI-Public04546540983930
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized5
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/23/2019
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 Catalogue Number5100131000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/24/2019
Initial Report FDA Received Date07/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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