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

Device Problem Migration (4003)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nail head elements: helical 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: zhang, w.Et al.(2020), risk factors for mechanical failure of intertrochanteric fractures after fixation with proximal femoral nail anti-rotation (pfna ii): a study in a southeast asian population, archives of orthopaedic and trauma surgery, vol.Xx, pages 1-7 (singapore).The aim of this study is to examine risk factors predisposing to mechanical failure of intertrochanteric fractures fixation with pfnaii in our southeast asian population to see if they correlate with prior studies and discuss implications for practice.In addition to radiologic parameters, we included an analysis of patient characteristics in our study.Between january 2014 and june 2018, a total of 204 patients were treated with a pfna-ii.There were 130 females and 74 males with an average age of 78.5, with a range of 41 to 95 years old.The following complications were reported as follows: patients who were excluded from the study.Patients with pfna ii failure mechanisms other than blade cut in/outs (n = 2).1 patient had infected nonunion.1 had implant breakage secondary to aseptic nonunion.22 patients had mechanical failure of pfna-ii.13 were blade cut-out.9 were blade cut-in cases.Among the 22 patients who had mechanical failure, 19 had acceptable quality of reduction among the 182 patients who didn't have mechanical failure, 79 had acceptable quality of reduction and 6 had poor reduction.Mechanical failure is defined as blade cut in or cut out in our study.Blade cut out is defined as perforation of the helical blade through the superior cortex of the femoral head or neck, followed by rotation and varus collapse of the head¿neck.Blade cut in is defined as the medial migration of the blade, with perforation of the blade tip into the hip joint without loss of reduction.(p.2).This report is for an unknown synthes pfna-ii.This report is for one (1) unk - nail head elements: helical blade.This is report 5 of 10 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: HELICAL 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: 11449322
• MDR Text Key: 239365224
• Report Number: 8030965-2021-01769
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• 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: 02/11/2021
• 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