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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS KALAMAZOO CORE SUMEX DRILL BONE CUTTING INSTRUMENT AND ACCESSORIES

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STRYKER INSTRUMENTS KALAMAZOO CORE SUMEX DRILL BONE CUTTING INSTRUMENT AND ACCESSORIES Back to Search Results
Catalog Number 5400130000
Event Date 10/02/2009
Event Type  Malfunction  
Event Description

It was reported that the drill gets hot. There is no report of user or pt injury as a result of this event. Several attempts were made to gather additional detail from the account without success.

 
Manufacturer Narrative

The handpiece was received at the mfr for investigation, and the alleged condition of the handpiece getting hot was confirmed. The rotor assembly and motor assembly were replaced. The handpiece has been returned to the account.

 
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Brand NameCORE SUMEX DRILL
Type of DeviceBONE CUTTING INSTRUMENT AND ACCESSORIES
Manufacturer (Section F)
STRYKER INSTRUMENTS KALAMAZOO
kalamazoo MI 49001
Manufacturer (Section D)
STRYKER INSTRUMENTS KALAMAZOO
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS KALAMAZOO
4100 east milham ave.
kalamazoo MI 49001
Manufacturer Contact
julie pryor
4100 east milham ave.
kalamazoo , MI 49001
(269) 323 -7700
Device Event Key1584541
MDR Report Key1532816
Event Key1459121
Report Number1811755-2009-00686
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/02/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5400130000
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/06/2009
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received10/02/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/25/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/28/2009 Patient Sequence Number: 1
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