MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: TFNA; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown tfna construct/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.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: unsay, j.D.C., chua tjun huat, i., and kwek beng kee, e.(2020), early experience with the trochanteric fixation nail-advanced (tfn-a): a descriptive review of thirty-four cases from a single center, indian journal of orthopaedics, vol.Xx (xx), pages 1-8 (singapore).The aim of this retrospective and descriptive study is to look at the early outcomes of the tfn-a as used in a single trauma centre in singapore.Between october 2016 to july 2018, a total of 40 patients underwent fixation.But only 34 patients (13 male and 21 female) with a complete follow-up, with a mean age of 79.7 years, except for one (age 34 years), were included in the study.Surgery was performed using the trochanteric fixation nail-advanced (tfn-a; synthes gmbh, oberdorf, switzerland).The mean follow-up period for the 37 patients were 5.8 months (ranged from 2 to 18 months).The following complications were reported as follows: 2 patients died of causes unrelated to the operation (both from myocardial infarction) before their scheduled follow-up.1 patient with a previous fixation failure (fixation with a pfna) who underwent revision fixation using the tfn-a.2 patients showed no radiographic signs of fracture healing at 2 months post-surgery; one of them was offered bone grafting (the procedure was cancelled because the patient had a non-fatal myocardial infarction and the patient¿s fracture eventually showed radiographic union 12 months post-surgery) and the other was commenced on anabolic treatment (teriparatide 80 mcg once daily), which induced callus formation at 5 months post-surgery.1 patient with a multiple-level femoral fracture (it and shaft) had delayed healing at the shaft section due to a large butterfly fragment, but at 6 months post-surgery demonstrated good fracture consolidation.2 of 34 patients had varus collapse of the fixation construct greater than 5° on follow-up but did not progress towards cut-out (one had cement augmentation and one did not).16 patients had shortening of the neck (15 helical blades and 1 lag screw), with 5 patients having more than 10 mm collapse (all blades).A (b)(6) year old female patient experienced a broken distal locking screw, however, the fracture united rather unremarkably, and the screw failure was noted on the 6-month follow-up.A (b)(6) year old male patient experienced 2 broken distal locking screws at 6 months post-op showing a united fracture.This is report 1 of 5 for (b)(4).This report is for an unknown synthes tfna constructs.

• Brand Name: UNK - CONSTRUCTS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10553932
• MDR Text Key: 207567419
• Report Number: 8030965-2020-07191
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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
• Date Manufacturer Received: 08/25/2020
• 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