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

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

Patient Problem Physical Asymmetry (4573)

Event Date 03/17/2011

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown.March 17, 2011 is the date the literature article was published.510k: this report is for an unknown synthes pfna/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: lv c., (2011) the new proximal femoral nail antirotation-asia: early results, orthopedics.Volume 34(5), pages e18-e23 (china).This study aims to evaluate the early clinical outcomes of unstable trochanteric fractures that were treated using this new design.From november 2009 to october 2010, eighty-four consecutive patients (60 females, 24 males) with a mean age of 79.5 years (range, 65-92 years) with unstable trochanteric fractures were included in this study.The modified nail of the proximal femoral nail anti-rotation asia (synthes gmbh, oberdorf, switzerland) was used.Follow-up evaluations, which included a clinical and radiographic assessment, were performed at 4, 12, 24, and 52 weeks.Patients were followed up for an average 8 months (range, 4¿11 months).The following complications were reported as follows: at most recent follow-up, 2 patients died within 4 months due to causes unrelated to the implant.5 poor fracture reduction.A tip-apex distance of 10 to 20 mm in 50% of patients.Figure 3: a (b)(6) year-old man (height, 155 cm; weight, 58 kg) underwent surgery using the smallest version of the standard proximal femoral nail antirotation (length, 170 mm).The proximal end of the nail is prominent.This report is for an unknown synthes pfna.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1 - brand name.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 - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12341796
• MDR Text Key: 267245877
• Report Number: 8030965-2021-06824
• 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: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention