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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 25.4 MM DIAMOND DISC
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DEPUY SYNTHES POWER TOOLS 25.4 MM DIAMOND DISC Back to Search Results
Catalog Number SIL-14
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Report received from the usa stating that the box they received from (b)(6) was damaged while in transit and one of the two burr packs was split open.The device was not being used during surgery.No injuries or medical intervention occurred as the damage was observed upon arrival of the packages.The date of event is unk.There was no additional information provided.
 
Manufacturer Narrative
The device was not received by depuy synthes power tools.Once the device is received and the evaluation has been completed or if additional information is received, a supplemental report will be sent.Ref: (b)(4).
 
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Brand Name
25.4 MM DIAMOND DISC
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 Key3908657
MDR Text Key15365659
Report Number1045834-2013-16418
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 09/07/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSIL-14
Device Lot NumberF203065283
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/07/2012
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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