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

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

Patient Problems Pain (1994); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown pfna constructs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: yanbin, l.Et al (2014), treatment of long-segment fracture at middle-up part of femur with long proximal femoral nail antirotation, the journal of the pakistan medical association, vol.64 (12 suppl.2), pages s64-69 (china).The aim of this retrospective study is to investigate the results of non-invasive operation method and evaluate clinical and radiological outcome of long proximal femoral nail antirotation in treating long-segment fracture at middle-up part of femur.Between june 2006 to december 2013, a total of 139 patients (104 male and 35 female), with a mean age of 48.8 (range 18-86) years, were included in the study.Surgery was performed using pfna-long.Follow-ups were performed at 1, 2, 3, 6, 9 and 12 months postoperatively, and at least once a year thereafter.The mean follow-up period was unknown.The following complications were reported as follows: 1 patient had poor harris hip functional score.2 patients developed coxa vara, crispation, and significant displacement of trochanter, pain in medial hip, increasing limb crispation, and partially limited range of motion (rom).4 cases of screw breakage with phase i non-union, shortening and angular deformity also got healed after the second operation, however, the patients had amyotrophy and limited motion of hip and knee joints.This report is for an unknown synthes pfna long constructs.It captures reported significant displacement of trochanter, pain in medial hip, increasing limb crispation, and partially limited range of motion (rom).This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA LONG
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12345072
• MDR Text Key: 267428015
• Report Number: 8030965-2021-06927
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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: 07/21/2021
• 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