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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY-SYNTHES QUICK COUPLING DRILL BIT

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DEPUY-SYNTHES QUICK COUPLING DRILL BIT Back to Search Results
Catalog Number 310.19
Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/11/2017
Event Type  Injury  
Event Description
Synthes catalog number 310.19 2 mm drill bit - retained foreign body due to a breakage of drill bit.Drill bit has been sequestered pending further investigation.
 
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Brand Name
QUICK COUPLING DRILL BIT
Type of Device
QUICK COUPLING DRILL BIT
Manufacturer (Section D)
DEPUY-SYNTHES
MDR Report Key6750654
MDR Text Key81384881
Report NumberMW5071268
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/26/2017
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 No Information
Device Catalogue Number310.19
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/26/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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