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

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna construct/ 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: brunner, a.Et al.(2016), what is the optimal salvage procedure for cut-out after surgical fixation of trochanteric fractures with the pfna or tfn? a multicentre study, injury, vol.47, pages 432-438 (austria).The purpose of the study was to evaluate the failure and success rates of salvage procedures for cutting-out and cutting-through of blades and to offer data-based recommendations on the optimal treatment strategy for each type of complication.Between 2003 and 2010, 57 patients underwent nailing of trochanteric fractures using pfna or tfn.These patients were divided into 2 groups.The cut-through group had 28 patients (22 females and 6 males) with a mean age of 77.8 years.The cut-out group had 29 patients (24 females and 5 males) with a mean age of 83.3 years.The following complications were reported as follows: 1 patient died after a follow-up period of 5.7 months for medical reasons unrelated to implant failure.21 patients had moderate reductions and 26 cases had poor reductions 28 patients had a cut-through of the helical blade (3 for tfn and 25 for pfna), all these patients had revision surgery.29 patients had a cut-out of the helical blade (7 for tfn and 22 for pfna), patients underwent metal removal and re-nailing of the fracture with a new pfna.One of these fractures healed.One patient developed re-perforation of the blade and required a second revision procedure with tha.One patient sustained a deep wound infection after re-nailing and required two more revision operations.Finally, the patient had a cement spacer inserted, which became the definite treatment this report is for an unknown synthes pfna construct.It captures the reported moderate and poor reductions.This is report 3 of 20 for (b)(4).Additional devices are reported under related complaints (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA SHORT
• 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: 12344773
• MDR Text Key: 267545101
• Report Number: 8030965-2021-06906
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2021
• 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