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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 NameQUICK COUPLING DRILL BIT
Type of DeviceQUICK 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
Date FDA Received07/26/2017
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
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/26/2017 Patient Sequence Number: 1
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