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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP HUDSON/MODIFIED TRINKLE DRILL ARTHROSCOPE

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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP HUDSON/MODIFIED TRINKLE DRILL ARTHROSCOPE Back to Search Results
Model Number 4100135000
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Manufacturer Narrative
Device discarded.
 
Event Description
The user facility reported that the device overheated during testing prior to a procedure. There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand NameHUDSON/MODIFIED TRINKLE DRILL
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12706031
MDR Text Key278621010
Report Number3015967359-2021-02410
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K112593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4100135000
Device Catalogue Number4100135000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
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

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