MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TFN; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Malunion of Bone (4529); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown tfn constructs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: mandal, s.Et al (2019), results of ¿trochanteric femoral nailing (tfn)¿ in comminuted unstable trochanteric fractures, acta orthopaedica belgica, vol.85 (4), pages 525-534 (india).The aim of this prospective and without control study is to evaluate the result of trochanteric femoral nailing in comminuted, unstable trochanteric femur fracture in terms of anatomical restoration and functional outcome.Between september 2011 to august 2014, a total of 25 patients with age range of 32-72 years, were included in the study.Surgery was performed using a trochanteric femoral nail (tfn).Clinical and radiological evaluation done at 2 weeks, 6 weeks, 12 weeks and then as required for the next 9 months.The mean follow-up period was unknown.The following complications were reported as follows: 3 patients had varus deformity (fig.12) in the range of (120-105) deg.Among them, post-operative nail breakage occurred in a case (at the site of a screw hole) (fig.13) and limb shortening happened in two cases.One of them had shortening of one cm and was associated with reverse z deformity (fig.14).Another one had shortening of two cm and that was associated with hip pain & significant ipsilateral knee stiffness.2 patients had a superficial wound infection.9 patients had a fracture gap noted on first post-operative x-ray.This report is for an unknown synthes tfn constructs.It captures the adverse events of varus deformity, limb shortening, reverse z deformity, hip pain, ipsilateral knee stiffness, superficial wound infection and fracture gap.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11401813
• MDR Text Key: 245492673
• Report Number: 8030965-2021-01539
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2021

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: 02/08/2021
• Initial Date FDA Received: 03/02/2021
• 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