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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (U.S.A.) LP TFN 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES (U.S.A.) LP TFN 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 456.315S
Device Problems Collapse (1099); Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994); Impaired Healing (2378); No Code Available (3191)
Event Date 06/15/2020
Event Type  malfunction  
Event Description
Notes from the h&p: the patient underwent a left intramedullary nail fixation of the left hip for an intertrochanteric fracture ~2 months ago. The patient's fracture has gone on to collapse and there has been hardware failure. The fracture has gone on to malunion, not healing, and hardware cutting out of the joint. Patient is in severe pain, and we discussed conversion to total hip replacement. Will also require removal of the rod. Notes from the op report: indications for operation: an elderly female who underwent an intertrochanteric fracture of the left hip with a synthes tfn nail that failed to heal and collapsed into varus with hardware cut out. Preoperative diagnosis: failed left hip fracture fixation, intertrochanteric fracture. Postoperative diagnosis: failed left hip fracture fixation, intertrochanteric fracture. Procedure performed: 1. Conversion of failed left hip fracture, intertrochanteric to total hip arthroplasty. 2. Open reduction and internal fixation greater trochanteric fracture. 3. Removal of deep femoral bone, hardware. Description of procedure: posterolateral hip incision was utilized, incorporating the old incisions. Skin and fascia was incised. Charnley c retractor was placed. I was able to visualize the cephalomedullary lag screw as it was protruding through the vastus lateralis. I then proceeded to identify the proximal aspect of the nail. The greater trochanteric area had a fibrous union and i was able to dissect through this and visualize the tip of the nail. I removed the one static distal locking screw. Then, i removed the proximal setscrew and subsequently the lag screw. The nail was extracted. The greater trochanteric fracture fragments did not heal, but the overall intertrochanteric area healed and malunion. The hip was posteriorly dislocated once i dissected off the short external rotators. I was able to dissect the capsule in a t-shape fashion. A femoral neck osteotomy was made basically at the level of lesser trochanter based on the fracture pattern. The head was extracted, as well as neck remnant. It measured around 44mm. We were able to sublux the femur forward. I removed the soft tissue and pulvinar and labrum. Peripheral acetabular retractors were placed. I reamed sequentially at 45 degrees of inclination and anteversion matching the _____. I had good line to line reaming and press-fit a 48-mm shell with a single inclination and anteversion. I placed 3 bone screws for adjunct fixation. A 38-mm liner was impacted for the mdm construct. We then proceeded to elevate the femur. Implants were stryker restoration hip system. I did by distal reaming. I had good cortical purchase with a size 15. The 155mm distal diameter stem was impacted. We then prepared the proximal body and a 21-mm seemed to be appropriate fit. I set this with a +0 neutral height. I then set her version along the calcar and cheated slightly anterior for some extra stability. I reduced the hip, initially with a -3 neck length. The hip still had a little bit of play to it. Additionally, the abductor mechanism had been disrupted through the greater trochanteric fracture. I went ahead and put a +3 on there and reduced the hip, which improved its stability. This plus restoration of the greater trochanteric fracture given hip stability. We used a small trochanteric claw plate and secured this with 2 dall-miles cables around the lesser trochanter. The hip was stable to full range of motion. The md noted: tfn that cutout at 2 months requiring tha. Upon inspection, it did appear that the internal lock prong was deformed/damaged on the implant.
 
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Brand NameTFN 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES (U.S.A.) LP
1210 ward ave
west chester PA 19380
MDR Report Key10400960
MDR Text Key202705544
Report Number10400960
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number456.315S
Device Catalogue Number456315S
Device Lot NumberH053179
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/06/2020
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer08/13/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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