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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO U SERIES ELITE LONG ANGLED ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO U SERIES ELITE LONG ANGLED ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5100010472
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/28/2020
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer field service technician reported that the device overheated while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
Event or Problem Description
The manufacturer field service technician reported that the device overheated while it was being demonstrated at the user facility.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
B5: noted during a demo visit.H3 other text : device not returned.
 
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Brand Name
U SERIES ELITE LONG ANGLED ATTACHMENT
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 Key10587866
Report Number0001811755-2020-02476
Device Sequence Number14158813
Product Code ERL
UDI-Device Identifier04546540348449
UDI-Public04546540348449
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
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) 03/19/2021
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 Other
Device Model Number5100010472
Device Catalogue Number5100010472
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/28/2020
Supplement Date Received by Manufacturer03/16/2021
Initial Report FDA Received Date09/25/2020
Supplement Report FDA Received Date03/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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