MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: LAG: PFNA; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown pfna lag screw/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: makki d., et al (2015) comparison of the reconstruction trochanteric antigrade nail (tan) with the proximal femoral nail antirotation (pfna) in the management of reverse oblique intertrochanteric hip fractures, injury, int.J.Care injured xxx xxx¿xxx , pages 1-5 (united kingdom).This retrospective consecutive study aims to compare the clinical outcomes of the reconstruction trochanteric antegrade nail (tan) with the proximal femoral nail anti-rotation (pfna) in the management of reverse oblique intertrochanteric hip fractures.Between july 2008 and february 2013, data of all patients with intertrochanteric fractures presented were evaluated.Fifty-eight patients with reverse oblique (ao-31.A3) were included in the final analysis, 36 patients (7 males,29 females) with a mean age of 80 (11.75) were treated with pfna (synthes), and 22 patients (9 males,13 females) with a mean age of 78(10.44) with trochanteric antegrade nail (tan, smith & nephew ).Proximal interlocking screws (2 screws for tan and blade for pfna) were inserted using the attached targeting device through stab incisions.All nails used were long.When successfully discharged from the hospital, patients were reviewed clinically and radiologically at 6 weeks initially then at variable intervals until satisfactory fracture union.The following complications were reported as follows: 2 patients died in the tan group.In the pfna group, there were 6 deaths in total and all were of unrelated causes.Four deaths occurred during the same hospital admission and 2 following discharge.(included in those who died were patients who did not achieve radiological union and one who underwent revision surgery).8 implant failures.(the pattern of implant failure was identical in all cases whereby the femoral neck fragment abducts and tilts into varus followed by lag screw cutting out.)7/8 patients with failed pfna underwent revision.Revision procedures included conversion to complex total hip replacement (3 patients), revision of fixation using trochanteric locking plate (3 patients), and removal of the cutout screw in a patient with poor mobility and were medically unfit for a reconstructive procedure (this patient died).Fig.2.(a¿f): follow up radiographs demonstrate the proximal fragment sliding into varus and the blade backing out with implant failure.11 radiological unions were not achieved.2 needed secondary procedures.(dynamization of the nail).Delayed union (figure 1).Two patients in the pfna developed wound infection.This report is for an unknown synthes pfna lag screw.This is report 3 of 10 for (b)(4).

• Brand Name: UNK - SCREWS: LAG: PFNA
• 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: 12338513
• MDR Text Key: 267237982
• Report Number: 8030965-2021-06791
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• 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: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2021
• 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