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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SD/PD SERIES XL PLUS ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-KALAMAZOO SD/PD SERIES XL PLUS ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5100120490
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/09/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device overheated during testing prior to a procedure.  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.Additional information: the account advised the device was not available to return.
 
Event or Problem Description
The user facility reported that the device overheated during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
SD/PD SERIES XL PLUS 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 Key8961789
Report Number0001811755-2019-02910
Device Sequence Number2399943
Product Code ERL
UDI-Device Identifier04546540370006
UDI-Public04546540370006
Combination Product (Y/N)N
Initial Reporter StateKY
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) 04/17/2020
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 Number5100120490
Device Catalogue Number5100120490
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/09/2019
Supplement Date Received by Manufacturer04/15/2020
Initial Report FDA Received Date09/04/2019
Supplement Report FDA Received Date04/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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