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

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

Patient Problems Necrosis (1971); Non-union Bone Fracture (2369); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown tfn construct/ unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between 2009 to 2015.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: parry, j.A.Et al.(2020), variables associated with lag screw sliding after single-screw cephalomedullary nail fixation of intertrochanteric fractures, journal of orthopedic trauma, vol.34, number 7, pages 356-358, (usa).The purpose of this study was to determine variables associated with lag screw sliding after single-screw fixation of intertrochanteric femur fractures.Between 2009 to 2015, a total of 158 patients with intertrochanteric fractures underwent a single-screw cmn.The average patient age was 75 years (49¿97 years), and there were 110 females and 48 males.Single-screw cmn implants included 104 gamma-3 nails (stryker, kalamazoo, mi) and 54 trochanteric fixation nails (synthes, raynam, ma).The average follow-up was 22 months (3¿94 months).Six-month follow-up was available for 140 patients.For the 18 patients with only 3 months of follow-up, all had healed radiographically.The following complications were reported as follows: 8 patients had varus collapse greater than 5 degrees 155 patients had fracture union.3 did not.6 patients had revision surgeries, 1 patient had avascular necrosis, 1 patient had loss of reduction, 1 patient had cutout, 2 patients had symptomatic lag screw removal.This report is for an unknown synthes trochanteric fixation nails.This report is for one (1) tfn construct.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TFN
• 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: 11413977
• MDR Text Key: 234968855
• Report Number: 2939274-2021-01171
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2021

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: 02/09/2021
• Initial Date FDA Received: 03/04/2021
• 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