MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEM: TFNA LAG SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown tfna lag screw/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.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.(b)(4).Device was used for treatment, not diagnosis.

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, 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).A copy of the literature article is being submitted with this medwatch.This is report 2 of 4 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEM: TFNA LAG SCREW
• Type of Device: ROD, 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 Key: 13543918
• MDR Text Key: 289341500
• Report Number: 8030965-2022-00918
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 02/16/2022
• 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?: Yes
• Date Manufacturer Received: 01/18/2022
• 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
• Patient Outcome(s): Required Intervention