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

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

A total of 392 patients (158 males and 234 females) with a mean age of 75.5¿13.4 (range, 20 to 101 years) were included in the study.Date of event: exact date of event is unknown, (b)(6) 2021 is the date the literature article was published.510k: this report is for an unknown pfna 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: karapinar, l., turgut, a., kumbaraci, m., and koca, a.(2021), evaluation of the quadrants of femoral neck-head in the cephalomedullary fixation of intertrochanteric fractures with a helical blade: is inferior posterior quadrant also safe? a clinical study, joint diseases and related surgery, vol.32 (1), pages 93-100 (turkey).The aim of this retrospective study is to investigate the positioning of the helical blade to prevent mechanical complications in surgically fixed intertrochanteric fractures (itfs).Between january 2009 to january 2017, a total of 392 patients (158 males and 234 females) with a mean age of 75.5¿13.4 (range, 20 to 101 years) were included in the study.Surgery was performed using proximal femoral nail anti-rotation (pfna) (pfna; synthes¿ oberdorf, switzerland).The mean follow-up period was unknown.The following complications were reported as follows: 19 patients had cut-out complications.In 65 patients, reductions were evaluated as in varus position (cda below than 130¿).56 patients had poor reductions.This report is for an unknown pfna blade.This is report 2 of 2 for (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.H3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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-II BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12341879
• MDR Text Key: 267249732
• Report Number: 8030965-2021-06830
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 09/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention