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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 1303 GOSHEN SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: TFNA ROD, FIXATION, INTRAMEDULLARY

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1303 GOSHEN SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: TFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Joint Dislocation (2374); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown tfna construct/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
This report is being filed after the review of the following journal article: hertig d. , thalmann r, rufer b (2020), injury of the profunda femoris artery with bleeding requiring transfusion due to secondary dislocation of the lesser trochanter after osteosynthesis of an intertrochanteric femoral fracture, der unfallchirurg, volume 124, page 167-171 (switzerland). This is a case report on a (b)(6)-year-old patient who suffered bleeding that required a transfusion after closed reduction and internal fixation of intertrochanteric femoral fracture with a proximal femoral nail. The patient was brought by the emergency services following an unobserved fall at a home for the elderly resulting in immobilizing hip pain on his left-hand side. The patient had previously been independently mobile using a rollator. On arriving at hospital, the patient was hemodynamically stable. Clinically, he presented tenderness on palpitation on the left lesser trochanter with immobilizing pain. X-rays presented an interruption in the contour between the greater trochanter and lesser trochanter plus advanced cox arthrosis on the left. Computed tomography revealed a non-dislocated intertrochanteric femoral fracture on the left, 31 a1. 3 pursuant to the ao classification. The lesser trochanter was still continuously joined to the calcar or the femoral head/neck fragment. The fracture line tapered off distally to the lesser trochanter in the metaphysis of femur. The patient underwent fracture osteosynthesis using the unknown synthes tfn-advanced proximal femoral nailing system (tfna). The postoperative x-ray checks revealed the anatomical positioning of the proximal femur, in particular the lesser trochanter. The patient was able to move the following day with a walking aid. On the second day postoperatively, the patient expressed increasing pain, and pronounced swelling was visible in the left upper thigh. In the conventional x-ray image, a dislocation of the lesser trochanter fragment was now visible in the cranial direction otherwise the proximal femur and intramedullary nail remained in the correct position. Despite transfusing a total of 4 units of packed red blood cells, his hemoglobin level fell to 7. 5 g/dl compared to 13. 3 g/dl preoperative baseline. Contrast medium computed tomography was used to identify the source of bleeding and revealed bleeding from a side branch of the profunda femoris artery. Most likely, the vessel wall was perforated by the tip of the lesser trochanter fragment which became secondarily dislocated during initial mobilization. The side branch of the pfa in question was embolized by the operating radiologists using coils. Thereafter, hemoglobin levels gradually rose again. In the clinical and radiological follow-up 6 weeks after the operation, the patient was mobile using a rollator and without pain, with warm periphery and intact sensory system. X-ray imaging revealed that the osteosynthetic material remained correctly positioned. This report is for the unknown synthes tfn-advanced proximal femoral nailing system (tfna). This report is for one (1) trochanteric fixation nail advanced (tfna) construct. This is report 1 of 1 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: TFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
1303 GOSHEN SYNTHES USA PRODUCTS LLC
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12199431
MDR Text Key262675286
Report Number2530088-2021-00015
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/20/2021 Patient Sequence Number: 1
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