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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LTD&1 1979 1/87; SAW, POWERED, AND ACCESSORIES

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STRYKER INSTRUMENTS-KALAMAZOO LTD&1 1979 1/87; SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 0940000000
Device Problem Device Remains Activated (1525)
Patient Problem No Patient Involvement (2645)
Event Date 09/30/2019
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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.
 
Event Description
This report summarizes 1 malfunction event in which the device had run-on.1 event had no patient involvement; no patient impact.
 
Event Description
This report summarizes 1 malfunction event in which the device had run-on.1 event had no patient involvement; no patient impact.
 
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 1 previously reported event is included in this follow-up record.Product return status 1 device was received.Event confirmation status 1 reported event was not confirmed.Evaluation results 1 device was found to be affected by failed internal electronics.
 
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Brand Name
LTD&1 1979 1/87
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9245095
MDR Text Key174156173
Report Number0001811755-2019-03421
Device Sequence Number1
Product Code HAB
UDI-Device Identifier07613327115147
UDI-Public07613327115147
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/27/2020
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 Number0940000000
Device Catalogue Number0940000000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/30/2019
Initial Date FDA Received10/28/2019
Supplement Dates Manufacturer Received09/30/2019
Supplement Dates FDA Received01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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