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

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

Patient Problem Joint Dislocation (2374)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nail head elements: pfna blade/unknown lot.Part and lot numbers 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: van der sijp, m.P.L.Et al (2021), high risks of failure observed for a1 trochanteric femoral fractures treated with a dhs compared to the pfna in a prospective observational cohort study, archives of orthopaedic and trauma surgery, vol xx (xx), pages 1-9 (netherlands).The aim of this single-centre observational cohort study was to compare the implant failure rates of the dhs and the pfna within 1 year after surgery in patients with 31a1 type trochanteric femoral fractures.In addition, other complications, and the potential influence of the implant choice on the long-term independence in activities of daily living were studied.Between december 21, 2016 to october 1, 2018, a total of 126 patients (31 male and 95 female) with a mean age of 81.2 years (sd, 12.3) who were surgically treated with a dhs (n = 32, 25.4%) or pfna (n = 94, 74.6%) were included in the study.The implant devices used were the dynamic hip screw (dhs) with a 2- or 4-hole dynamic compression plate and the short or long proximal femoral nail antirotation (pfna), both produced by johnson-johnson depuy synthes.Radiological assessments of the hip were routinely made at 6 weeks and 3 months (and when indicated 1 year after surgery).The mean follow-up was 9.8 (sd, 3.9) months.The following complications were reported as follows: dhs group: 2 patients died before discharge due to non-surgical complications.6 patients died in total within the 1-year follow-up period.In 13.3% of patients, an inadequate tad was observed.1 patient had tad > 25 mm.9 patients had poor reduction.8 patients had implant failure.The primary reason of failure was a fragile lateral cortex which dislocated or collapsed in 5 of the 8 dhs cases.Two failures in the dhs group had a very long lag screw (> 90 mm measured from the barrel) and collapse of the trochanteric region with an intact lateral cortex, and one was due to a non-union with no identified underlying cause.2 patients underwent revision and 6 were managed conservatively.9 patients had readmissions.2 patients had reoperations.3 patients had a mechanical failure.All three concerned breakages of cortical screws.Only 1 patient who had an implant failure and a subsequent mechanical failure underwent a revision operation.Another mechanical failure concerned a single broken cortical screw, and the third patient with a mechanical failure had a revision outside the study¿s follow-up period of 1 year.Pfna group: 14 patients died in total within the 1-year follow-up period.In 15.2% of patients, an inadequate tad was observed.3 patients had tad > 25 mm.28 patients had poor reduction.22 patients had readmission.4 patients had reoperations.1 patient had implant failure (a valgus reduction with collapse of the medial trochanteric region and hyper-dynamization of the blade) and underwent revision.This report is for an unknown synthes dhs constructs, unknown synthes pfna constructs, unknown synthes dhs lag screw, unknown synthes dhs cortex screws, and unknown synthes pfna blade.

• 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
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12167467
• MDR Text Key: 271440444
• Report Number: 8030965-2021-05725
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/14/2021
• 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