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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 19CM ATTACHMKENT, BM; SURGICAL DRILL ATTACHMENT
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DEPUY SYNTHES POWER TOOLS 19CM ATTACHMKENT, BM; SURGICAL DRILL ATTACHMENT Back to Search Results
Catalog Number B-BLACK_LL
Device Problem Overheating of Device (1437)
Patient Problem No Information (3190)
Event Date 07/12/2012
Event Type  malfunction  
Event Description
Report received from the usa stating that the device was being returned for service.During service of the device heat was noted.It is unknown if the device was being used in surgery or if injury or medical intervention occurred.There was no additional information provided.
 
Manufacturer Narrative
The device was received by depuy synthes power tools.The device was evaluated, and during service the device failed the temperature test.If additional information becomes available a supplemental report will be submitted.(b)(4).
 
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Brand Name
19CM ATTACHMKENT, BM
Type of Device
SURGICAL DRILL ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
palm beach gardens FL
Manufacturer Contact
rodney crain
4500 riverside dr.
palm beach gardens, FL 33410
5614943766
MDR Report Key4616867
MDR Text Key18543848
Report Number1045834-2013-16404
Device Sequence Number1
Product Code GFF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/12/2012
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
Device Operator Other
Device Catalogue NumberB-BLACK_LL
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/11/2012
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/12/2012
Initial Date FDA Received04/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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