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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP D58 FOOTED DURAGUARD; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP D58 FOOTED DURAGUARD; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400210058
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/24/2021
Type of Reportable Event Malfunction
Event or Problem Description
The customer reported that the device overheated during testing prior to a procedure at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The customer reported that the device overheated during testing prior to a procedure at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
 
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Brand Name
D58 FOOTED DURAGUARD
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12353543
Report Number3015967359-2021-01858
Device Sequence Number3332925
Product Code ERL
UDI-Device Identifier04546540469205
UDI-Public04546540469205
Combination Product (Y/N)N
Initial Reporter CountryIN
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/01/2021
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 Number5400210058
Device Catalogue Number5400210058
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 07/24/2021
Supplement Date Received by Manufacturer10/29/2021
Initial Report FDA Received Date08/23/2021
Supplement Report FDA Received Date11/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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