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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA); APPLICATION, FIXATION, NAIL

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SYNTHES (USA); APPLICATION, FIXATION, NAIL Back to Search Results
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problems Sedation (2368); Non-union Bone Fracture (2369); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Patient weight is not available for reporting.Date of non-union and device breakage is not known.This report is for an unknown trochanteric fixation nail.Part and lot numbers are unknown; udi number is unknown.Date of implant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant devices therapy date is not known.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.(b)(4).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
It was reported that a patient, who was implanted with a trochanteric fixation nail, helical blade and two (2) 5.0 mm distal locking screws at an unknown hospital on an unknown date, experienced a post-operative nonunion at the fracture site.The patient underwent a revision surgery on (b)(6) 2017, where the previously implanted devices were removed and the patient was revised to an unknown proximal femoral plate, unknown screws, cancellous chips and bone graft material (bmp).During the revision surgery the nail was noted to be broken at the interchange where the nail and helical blade interconnect; as such it was extremely difficult to remove leading to a 4-hour surgical delay.The surgeon reportedly made a pretty big initial incision to allow for the implantation and proceeded to remove the threaded, proximal portion of the nail.The distal portion of the nail had no threads and could not be grabbed or easily removed.The surgeon over reamed the bone and used two (2) long synthes reaming rods putting them through the nail and down the distal hole.Using a t-handle chuck, the surgeon began hammering at the handle with the hammer to back the nail out.The surgeon additionally used a tamp right at the fracture site and tamped away in an upward motion and the nail backed away even more until the nail could be successfully grabbed with clamps and removed.As the surgeon had already over-reamed the bone (17 mm longer) and did not want to insert a second reamer he opted not to use the reamer/irrigator/aspirator (ria) to collect bone graft material as planned and decided instead to use cancellous chips and bone graft material (bmp).The surgery took approximately six (6) hours to complete, with the majority of time spent attempting to remove the nail.There was an approximate four-hour delay due to the intra-operative events.It was noted that the patient lost a lot of blood, perhaps more than usual but did not require a blood transfusion during the surgery.The reporter stated that she left the operating room as the patient was being closed but the patient was unharmed and in stable condition when she left.Concomitant devices reported: 5.0 mm distal locking screws (quantity 2), helical blade (quantity 1).This report is for one (1) unknown trochanteric fixation nail this is report 1 of 1 for (b)(4).
 
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Type of Device
APPLICATION, FIXATION, NAIL
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6657380
MDR Text Key78091010
Report Number2520274-2017-11829
Device Sequence Number1
Product Code KTT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 05/24/2017
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? No
Initial Date Manufacturer Received 05/24/2017
Initial Date FDA Received06/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
DISTAL LOCKING SCREW (PART/LOT UNKNOWN, QTY 2); HELICAL BLADE (PART AND LOT UNKNOWN, QTY 1)
Patient Outcome(s) Required Intervention;
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