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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA
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SYNTHES USA Back to Search Results
Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2013
Event Type  malfunction  
Event Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: while attempting to assemble the nail to the insertion arc some difficulty was found with threading the fluted nut in the conic nozzle.This prevented the nail from being coupled to the insertion arc.The nut was replaced with one from the femur system, which allowed for an appropriate coupling of the nail and the insertion arc.The specialist attempted to insert the nail but while trying to insert the impact device, the nail could not be screwed again.It was decided not to implant the nail to prevent more complications.A system from another manufacturer was requested.This report is for an unknown nail.This is report 3 of 3 for complaint (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.This is for one unknown nail.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.Placeholder.
 
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Manufacturer (Section D)
SYNTHES USA
west chester PA
Manufacturer Contact
w. lindenmuth
1302 wrights lane east
west chester, PA 19380
8006207025
MDR Report Key3553038
MDR Text Key4214884
Report Number2520274-2013-07926
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 09/26/2013
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 Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/26/2013
Initial Date FDA Received01/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Age18 YR
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