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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TFNA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH UNK - CONSTRUCTS: TFNA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Necrosis (1971); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: 510k: 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: schmitz p. , et al (2022) increased failure rates after the introduction of the tfna proximal femoral nail for trochanteric fractures: implant related or learning curve effect?, acta orthopaedica volume 9, pages 234¿240 (the netherlands). This study aims to compare trochanteric fracture fixation failure rates between the 2 intramedullary nails, gamma trochanteric nail (gtn3) and the tfn-advanced proximal femoral nailing system (tfna) and evaluate the responsible underlying mechanisms of failure. Between june 2011 and july 2019, all patients treated with an intramedullary nail following a trochanteric fracture were screened. 1,377 intramedullary nails were implanted in 1,353 consecutive patients. In 562 (556 patients) trochanteric fractures a tfna (depuy synthes, west chester, pa, usa) was placed, and 815 (797 patients) trochanteric fractures were treated with a gtn3. After exclusion of 20 patients in the tfna group and 18 patients in the gtn3 group due to a pathologic fracture, 542 (536 patients, 164 males and 378 females with mean age of 79 (14) years) tfnas and 797 (779 patients, 589 females with mean age of 80 (12) years) gtn3s were included in this study. A blade was used within the tfna in all patients above 70 years old. The following complications were reported: 4. 8 % cut-out, blade/screw, clear migration of hardware in the femoral head , 0. 6 % implant breakage , 1. 5 % malpositioning screw/blade, requiring early re-intervention. , 1. 6 % non-union , 5. 2 % new fracture around the nail ,and 1. 2 % miscellaneous (failures from collapse of the femoral head, either post-traumatic or from avascular necrosis. This report is for an unknown synthes tfn-advanced proximal femoral nailing system (tfna). This is report 4 of 4 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: TFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13544002
MDR Text Key285965612
Report Number8030965-2022-00921
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2022
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
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/16/2022 Patient Sequence Number: 1
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