MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: TFN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK - CONSTRUCTS: TFN

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Literature citation: goodnough, l.H.Et al.(2022), risk of revision after hip fracture fixation using depuy synthes trochanteric fixation nail or trochanteric fixation nail advanced, the journal of bone and joint surgery, vol.00, pages 1-8 (usa) the investigation could not be completed; no conclusion could be drawn, as no product was received.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: goodnough, l.H.Et al.(2022), risk of revision after hip fracture fixation using depuy synthes trochanteric fixation nail or trochanteric fixation nail advanced, the journal of bone and joint surgery, vol.00, pages 1-8 (usa).The primary purpose of this study was to evaluate the risk of revision related to the index fracture following hip fracture repair.Using the tfna compared with the tfn in a large u.S.Integrated health-care system.The secondary aims were to characterize the risks of specific revision reasons between the tfn and the tfna and between the tfna blade and screw designs.The study sample comprised patients who underwent cephalomedullary nail fixation for hip fracture with a tfn (n = 4,007) or tfna (n = 3,972) from 2014 to 2019.The median age was 82 years (iqr, 74, 88 years).The following complications were reported as follows: tfn/tfna: 1,869 patients died at a median time of 1.5 years.Tfn: revision reason: (n=44) fixation failure, (n=23) nonunion, (n=8) fracture, (n=1) infection, (n=2) implant breakage (1 was due to aperture failures related to the index fracture), (n=43) cut-out.Tfna: revision reason, (n=41) fixation failure, (n=35) nonunion, (n=8) fracture, (n=2) infection, (n=5) implant breakage (3 were due to aperture failures related to the index fracture), (n=33) cut-out.This report is for an unknown synthes tfn and tfna.A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: TFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14250476
• MDR Text Key: 290394003
• Report Number: 2939274-2022-01540
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• 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: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: TFN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• 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?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention