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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 Sedation (2368)
Event Date 10/09/2015
Event Type  Injury  
Manufacturer Narrative
Device not reportedly explanted.(b)(6).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.
 
Event Description
Device report from synthes (b)(4) reports an event in the (b)(6) as follows: surgery took place to implant a retrograde antigrade femoral nail (rafn).During one surgery, after finishing the proximal locking, the surgeon tried to remove the jig from the nail by using the screwdriver to undo the jig bolt to the connection of the top of the nail.However it would not disengage and took apparently over an hour to get it out.During a second surgery, this event occurred again when the sales consultant was in a retrograde/antegrade femoral nail case and the jig bolt, jig and nail seemed to lock incorrectly and would not disengage.This may have been caused by soft tissue tensioning on the jig but this was checked before inserting the nail and it seemed to work normal.The nail was hammered in so this could have possibly affected the patient's leg.The patient's leg was adjusted to the adducting position so it could become easier to remove.The release of the jig bolt, jig and nail was still very tight and the procedure was prolonged sixty (60) minutes.There was reportedly no patient harm.This report is for the events that occurred during the second surgery; the events of the first surgery are reported in (b)(4).This report is for one (1) unknown nail.This is report 3 of 3 for (b)(4).
 
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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 Key5184576
MDR Text Key29733313
Report Number2520274-2015-16890
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Report Date 10/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
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 Not provided
Initial Date FDA Received10/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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