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

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

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown pfn constructs/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: codesido, p., mejía, a., riego, j., ojeda-thies, c.(2017), subtrochanteric fractures in elderly people treated with intramedullary fixation: quality of life and complications following open reduction and cerclage wiring versus closed reduction, archives of orthopaedic and trauma surgery, vol.137, pages 1077¿1085 (spain).The aim of this prospective cohort and retrospective observational study is to compare the results in fragility-type subtrochanteric fractures treated with cephalomedullary nails, after minimal open reduction assisted by cerclage wires, with those observed following closed, indirect reduction (as chosen by the surgeon at the time of surgery), with special emphasis on hrqol, quality of reduction, and postoperative orthopaedic complications.Between january 2009 to december 2012, a total of 90 patients (17 male and 73 female) with a mean age of 83.52 (±7.87) were treated with cephalomedullary nails.These patients were divided to 2 different groups: one treated with closed or percutaneous reduction maneuvers (60 patients) and another using open reduction and cerclage wires (30 patients).Only 2 patients were implanted with pfn nail (synthes, west chester, pa) with no cerclage wires and the rest were implanted with a competitor device.All patients had a minimum 2-year follow-up.The following complications were reported as follows: an unknown number of patients achieved poor reduction.1 patient had a superficial infection.Case 1 had varus malposition of the fracture.An unknown number of patients had nonunion.An unknown number of patients had a peri-implant fracture.An unknown number of patients had cut-out needing reoperation.An unknown number of patients died after 1-year.This is report 3 of 3 for (b)(4).This report is for an unknown synthes pfn constructs.

• Brand Name: UNK - CONSTRUCTS: PFN
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9720847
• MDR Text Key: 191861280
• Report Number: 8030965-2020-01199
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• 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: 02/10/2020
• 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