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

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).

• 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 Key: 6657380
• MDR Text Key: 78091010
• Report Number: 2520274-2017-11829
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DISTAL LOCKING SCREW (PART/LOT UNKNOWN, QTY 2); HELICAL BLADE (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention