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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES NAIL, FIXATION, BONE INTERMEDULLARY NAIL

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SYNTHES NAIL, FIXATION, BONE INTERMEDULLARY NAIL Back to Search Results
Catalog Number 448642
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem No Code Available (3191)
Event Date 05/24/2018
Event Type  Injury  
Event Description
Handle on synthes nail would not disengage requiring removal and new one placed. A small fragment of the nail was later noted to be broken and found in the pt's knee.
 
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Brand NameNAIL, FIXATION, BONE
Type of DeviceINTERMEDULLARY NAIL
Manufacturer (Section D)
SYNTHES
MDR Report Key7600557
MDR Text Key111153712
Report NumberMW5077838
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number448642
Device Lot NumberH302064
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: 06/13/2018 Patient Sequence Number: 1
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