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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 Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2014
Event Type  malfunction  
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: the complaint received states that the drill in question was interfering with the nail.There was no anomaly when assembled all devices outside of the patient body before use.It was reported that the surgeon complained that the drill in question was dull and it encumbered the procedure.There was a 10 minute delay reported.This report is for an unknown nail.This is report number 2 of 4 for (b)(4).
 
Manufacturer Narrative
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 Key4062956
MDR Text Key20781302
Report Number2520274-2014-13450
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 08/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2014
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 Received08/07/2014
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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