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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 Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2014
Event Type  malfunction  
Event Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: surgeon had a problem to meet the proximal hole in the expert hind foot arthrodesis nail (han) during surgery.After the drilling of the dynamic hole, the drill was left in place, which would mean that the most proximal hole should be possible to drill without any problem.The drill was bent slightly to meet the hole.No consequence to the patient was reported.There was a surgery delay of 5 minutes.This report is on an unknown nail.This report is 1 of 3 for complaint (b)(4).
 
Manufacturer Narrative
Device is used for treatment, not diagnosis.(b)(6).Report is for an unknown nail, quantity 1.Cannot be determined without a part number.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.Placeholder.
 
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Manufacturer (Section D)
SYNTHES USA
west chester PA
Manufacturer Contact
jodi temple
1302 wrights lane east
west chester, PA 19380
8006207025
MDR Report Key3631681
MDR Text Key4205967
Report Number2520274-2014-00592
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeSZ
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 01/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2014
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 Received01/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
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