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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 Overheating of Device (1437)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/21/2020
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer sales representative 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
Additional information: d10 device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The manufacturer sales representative 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.
 
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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 Key10167239
Report Number0001811755-2020-01494
Device Sequence Number1762458
Product Code ERL
UDI-Device Identifier04546540373526
UDI-Public04546540373526
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/23/2020
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 Number5100120452
Device Catalogue Number5100120452
Device Lot Number17235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2020
Initial Date Received by Manufacturer 05/21/2020
Supplement Date Received by Manufacturer07/22/2020
Initial Report FDA Received Date06/18/2020
Supplement Report FDA Received Date07/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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