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

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

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Pma/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: huang c & wu xi (2021), surgical selection of unstable intertrochanteric fractures: pfna combined with or without cerclage cable, hindawi biomed research international, volume 2021, article id 8875370, 12 pages (china).This study is aimed at comparing the clinical efficacy of pfna combined with cerclage cable and without cerclage cable and finally recommend a stable internal fixation method to provide the basis for clinical therapy.From january 2014 to january 2018, 120 elderly patients with unstable intertrochanteric fractures who received treatment and with continuous follow-up for one year were included in the study.All patients underwent fixation and were implanted with the unknown synthes proximal femoral nail antirotation (pfna).The patients were divided into 2 groups.51 patients (13 men and 38 women with a mean age of 83.0+/-10.6 years) were treated in combination with cerclage cable (pfna+cable group).Meanwhile 69 patients (18 men and 51 women with a mean age of 84.7+/-7.5 years) were treated without cerclage cable (pfna group).After operation, we actively prevent complications such as pulmonary infection, venous thrombosis, bedsore, urinary system infection, and osteoporosis, urge patients to actively carry out rehabilitation exercise to prevent joint stiffness, and promote bone reconstruction.Harris hip score (hhs) and barthel index (bi) were first evaluated before operation, and then, hhs, bi, and radiographic union scale for hip (rush)were evaluated at 1, 3, 6, and 12 months after operation, respectively.Complications were reported as follows: pfna group 3 patients had deep wound infection.All patients received debridement and antibiotic treatment.2 patients needed vsd treatment to promote wound healing.The wounds of all patients with deep infection healed well.1 patient had fracture nonunion and underwent secondary surgery.2 patients had screw penetration and underwent secondary surgery.1 patient had screw cut-out and underwent secondary surgery.Unknown patients had fracture nonunion at 12 months postoperatively and were treated with total hip replacement.Pfna+cable group: 2 patients had deep wound infection.All patients received debridement and antibiotic treatment.1 patient needed vsd treatment to promote wound healing.The wounds of all patients with deep infection healed well.This report is for an unknown synthes proximal femoral nail antirotation (pfna) construct.It captures reported deep wound infection and nonunion, revised.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA-II
• 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: 12350188
• MDR Text Key: 267816175
• Report Number: 8030965-2021-06999
• 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: Physician
• 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: 08/20/2021
• 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