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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MEDIUM ANGLED ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO MEDIUM ANGLED ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5100120452
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/20/2020
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer service technician reported that the device was returned with an alleged oil leak.The event occurred during an inspection.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The manufacturer service technician reported that the device was returned with an alleged oil leak.The event occurred during an inspection.There were no adverse consequences related to this event.
 
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Brand Name
MEDIUM 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 Key10804953
Report Number0001811755-2020-03076
Device Sequence Number3419616
Product Code ERL
UDI-Device Identifier04546540373526
UDI-Public04546540373526
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) 01/22/2021
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 Number5100120452
Device Catalogue Number5100120452
Device Lot Number15225
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Initial Date Received by Manufacturer 10/20/2020
Supplement Date Received by Manufacturer01/21/2021
Initial Report FDA Received Date11/06/2020
Supplement Report FDA Received Date01/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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