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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Necrosis (1971); Non-union Bone Fracture (2369); Malunion of Bone (4529); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown constructs: tfna/unknown lot.Part and lot numbers 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.(b)(4).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: sadeghi, c., prentice, h.A., okike, k.M., and paxton, e.W.(2020), treatment of intertrochanteric femur fractures with long versus short cephalomedullary nails, the permanente journal, vol.24 (19), pages 1-5 (usa).The aim of this retrospective cohort study is to evaluate the association between cephalomedullary nail length and outcomes for the treatment of intertrochanteric femur fractures.Between 2009 to 2014, a total of 5526 patients who underwent surgical treatment with cephalomedullary nails: 3108 (56.2%) with long nails and 2418 (43.8%) with short nails, were included in the study.Surgery was performed using trochanteric femoral nail (tfn, depuy synthes, west chester, pa) or a competitor device.The mean follow-up period was unknown.The following complications were reported as follows: there were 2027 deaths (36.7%).96 patients had all-cause revision.50 (1.6%) were using long nails and 46 (1.9%) were short nails.52 patients had revisions for fixation failure or symptomatic implant.1 patient had revision for infection.3 patients had revision for osteonecrosis.9 patients had revision for posttraumatic osteoarthritis.27 patients had revision for periprosthetic fracture.2 patients had revision for malunion.17 patients had revision for nonunion.This report is for an unknown synthes tfna constructs.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11392065
• MDR Text Key: 240740705
• Report Number: 2939274-2021-01085
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/01/2021
• 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