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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
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2021
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: 3 events were reported for this quarter.Product return status: 3 devices were received.3 devices were not labeled for single-use.3 devices were not reprocessed or reused.
 
Event 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
Type of Device
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key12203294
MDR Text Key262670301
Report Number3015967359-2021-01454
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540983930
UDI-Public04546540983930
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/21/2021
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 Number5100131000
Device Catalogue Number5100131000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/30/2021
Initial Date FDA Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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