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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, BONE
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SYNTHES USA; NAIL, FIXATION, BONE Back to Search Results
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2014
Event Type  malfunction  
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: the screw driver was used for a trochanteric fracture case.The surgeon had difficulty in connecting the screw driver to the end cap; although attempted over thirty minutes, the surgeon was not able to connect them.Therefore, the surgeon used a hollow screw driver to insert the end cap.This report is for an unknown end cap.This is report 2 of 2 for (b)(4).
 
Manufacturer Narrative
This report is for an unknown end cap/unknown lot.Device has not been explanted.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key3924460
MDR Text Key4584075
Report Number2520274-2014-12489
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2014
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
Date Manufacturer Received06/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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