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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 Patient Involvement (2645)
Date of Event 03/02/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events 1 event was reported for this quarter   product return status 1 device was received for evaluation.Evaluation status 1 event was confirmed during testing.1 device was found to be affected by a missing component.Product disposition the device was repaired and returned to the user facility.  additional information there were no remedial actions taken on this device.This device is not labeled for single-use.
 
Event or Problem Description
This report summarizes malfunction event in which the device had a component detach.1 event 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 Key7714834
Report Number0001811755-2018-01231
Device Sequence Number16476167
Product Code EIA
UDI-Device Identifier04546540983930
UDI-Public04546540983930
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/24/2018
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)Thirty-Day
Initial Date Received by Manufacturer 03/02/2018
Initial Report FDA Received Date07/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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