MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The cut-out group had 29 patients (24 females and 5 males) with a mean age of 83.3 years.Pma/510k: this report is for an unknown helical blade/unknown lot.Part and lot number 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: 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 helical blade.This is report 7 of 20 for (b)(4) which captures cut-out of the helical blade and revision surgery.Additional complications are captured on related complaints (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d1: impacted product change updated.H3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: UNK - NAIL HEAD ELEMENTS: PFNA BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12349388
• MDR Text Key: 267637129
• Report Number: 8030965-2021-06978
• 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,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention