MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Unspecified Infection (1930); Irritation (1941); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.This report is for an unknown pfna blade.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.[(b)(4)].

Event Description

This report is being filed after the subsequent review of the following literature article: c.Jiamton, et al.(2017).The nail-shaft-axis of the of proximal femoral nail antirotation (pfna) is an important prognostic factor in the operative treatment of intertrochanteric fractures.Archives of orthopaedic and trauma surgery, springer nature, pp.1-11.Germany.The purpose of the study was to analyze the complication rates and risk factors for implant-related complications in patients treated with the synthes proximal femoral nail-advanced (pfna) to repair intertrochanteric fractures.The study was conducted between january 2012 and january 2016, included 101 patients (80 female, 21 male), all with a median age of 81.8 years.Each patient was treated for an intertrochanteric fracture using the synthes pfna system.All patients were evaluated using pre-operative radiographs of the fracture site, as well as 6 and 12 weeks postoperatively to assess implanted devices and fracture union.The following complications were reported: eight total non-implant related complications included: 3 superficial surgical site infection (ssi), 2 patients presented with secondary varus displacement more than 10 degrees, 2 patients presented with delayed union, and 1 patient presented with nonunion.Sixteen total implant related complications included: 7 patients presented with a blade penetration into the hip joint (cut-out), 7 patients presented with irritation around the affected hip, 1 patient presented with nail breakage, and 1 patient presented with a displaced fracture of the greater trochanter.Twenty total revisions occurred without alleged malfunction against devices: 6 patients were revised to arthroplasty, 5 patients were revised to a shorter blade, 3 patients underwent debridement and wound revision, 2 patients underwent revision to longer nails, 2 patients had the nail removed, 1 patient underwent dynamization, and 1 patient underwent fixation of the greater trochanter.This report is for an unknown pfna blade (part #: unknown, lot #: unknown, qty.1).This report is for the patients who experienced the following: 3 superficial surgical site infection (ssi), 2 patients with secondary varus displacement more than 10 degrees, 2 patients with delayed union, 1 patient with nonunion, 7 patients with irritation around the affected hip, and 1 patient with a displaced fracture of the greater trochanter, 6 patients were revised to arthroplasty, 5 patients were revised to a shorter blade, 3 patients underwent debridement and wound revision, 2 patients underwent revision to longer nails, 2 patients had the nail removed, 1 patient underwent dynamization, and 1 patient underwent fixation of the greater trochanter.This is report 1 of 4 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7357900
• MDR Text Key: 103082961
• Report Number: 8030965-2018-52282
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/22/2018

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: 02/22/2018
• Initial Date FDA Received: 03/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention