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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES LATERAL ENTRY NAIL SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES LATERAL ENTRY NAIL SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2016
Event Type  malfunction  
Event Description
During repair of left femur, physician noted that a portion of the instrument guide was missing. All pieces accounted for, no patient harm.
 
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Brand NameLATERAL ENTRY NAIL SYSTEM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES
1301 goshen parkway
west chester PA 19380
MDR Report Key5802639
MDR Text Key49901218
Report Number5802639
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2016
Event Location Hospital
Date Report to Manufacturer07/12/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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