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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON/MODIFIED TRINKLE DRILL; ARTHROSCOPE
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HUDSON/MODIFIED TRINKLE DRILL; ARTHROSCOPE Back to Search Results
Model Number 4100135000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device discarded.
 
Event or Problem 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 Name
HUDSON/MODIFIED TRINKLE DRILL
Common Device Name
ARTHROSCOPE
MDR Report Key12706031
Report Number3015967359-2021-02410
Device Sequence Number4498790
Product Code HRX
UDI-Device Identifier04546540068194
UDI-Public04546540068194
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/27/2021
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
Operator of Device Health Professional
Device Model Number4100135000
Device Catalogue Number4100135000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/01/2021
Initial Report FDA Received Date10/27/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
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