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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REMB ELECTRIC WIREDRIVER; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO REMB ELECTRIC WIREDRIVER; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 6400062000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/01/2021
Type of Reportable Event Malfunction
Event or Problem Description
The device overheated during a service visit at the user facility.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
REMB ELECTRIC WIREDRIVER
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key12507318
Report Number3015967359-2021-02048
Device Sequence Number5338149
Product Code ERL
UDI-Device Identifier07613154945801
UDI-Public07613154945801
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/21/2021
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
Operator of Device No Information
Device Model Number6400062000
Device Catalogue Number6400062000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/01/2021
Initial Report FDA Received Date09/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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