MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PFNA; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Between march 2008 and april 2015, a total of 33 patients (19 males and 14 females) with a mean age of 54.64±18.94 were treated with a pfna device (synthes, oberdorf, switzerland).This report is for an unknown pfna construct/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: imerci, a., aydogan, n., and yosun, k.(2018), a comparison of the intertan nail and proximal femoral fail antirotation in the treatment of reverse intertrochanteric femoral fractures, acta orthopaedica belgica, vol.84, pages 123-131 (turkey).The aim of this study was to compare the clinical and radiological results of intertan nail and proximal femoral nail antirotation (pfna) in the treatment of reverse intertrochanteric fractures where the lateral cortex was fractured.Between march 2008 and april 2015, a total of 33 patients (19 males and 14 females) with a mean age of 54.64±18.94 were treated with a pfna device (synthes, oberdorf, switzerland).The minimum follow-up was 1 year.The following complications were reported as follows: patients needed a second surgery because of mechanical failure: 1 patient had a symptomatic nonunion which needed a revision surgery.This report is for an unknown pfna construct.This is report 2 of 9 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9535222
• MDR Text Key: 189166513
• Report Number: 8030965-2019-71548
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• 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
• Date Manufacturer Received: 12/17/2019
• 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