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

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown tfna 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: nayar, s.K.Et al.(2021), implant fracture of the tfna femoral nail, journal of clinical orthopaedics and trauma, vol.22, pages 1-6 (united kingdom) the aim of this study was to evaluate all tfna implant fractures at a uk trauma unit to ascertain any patient or surgical factors associated with implant failure.From june 2017 to december 31, 2020, a total of 127 fixations using the tfna for proximal femur fractures were performed.The mean age at the time of index surgery was 72.1 years.The following complications were reported as follows: 6 cases of implant fracture at the aperture for the proximal screw occurred, of which two occurred in the same patient.All six cases displayed radiographic nonunion at the time of implant fracture.All cases underwent revision surgery.1 case was revised to a six-hole dynamic hip screw (depuy synthes).1 case was revised to a cemented hemiarthroplasty (excia® hip stem system, bbraun).1 case was revised to an uncemented total hip replacement (bicontact® hip stem system, bbraun).2 cases were exchanged to further tfna nails.This occurred in the same patient, where an initial broken tfna was exchanged for a further tfna, this subsequently broke thus necessitating the proximal femoral replacement.1 case underwent a proximal femoral replacement at a tertiary referral unit.Reduction quality was considered good in two cases, acceptable in two cases and poor in the remaining two.This report is for an unknown synthes tfna construct.It captures the reported event of reduction quality was poor in 2 cases.A copy of the literature article is being submitted with this medwatch.This is report 4 of 9 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12739227
• MDR Text Key: 279673515
• Report Number: 8030965-2021-09210
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2021
• 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