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 Bone Fracture(s) (1870); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Pma/510k: this report is for an unk - constructs: pfna-ii/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: pan s., et al (2017) a novel modified trochanteric entry portal and percutaneous technique for asian patients: a prospective randomized study of the pfna-ii in china, int j clin exp med volume 10(3), pages 4669-4677 (china).This study aims to compare the clinical outcomes of intertrochanteric fractures in chinese patients treated with a pfna-ii inserted using a novel modified trochanteric entry portal and percutaneous technique to those treated with a conventional trochanteric entry portal and operative technique with closed reduction.From may 2010 to december 2013, 176 consecutive patients with intertrochanteric femoral fractures treated at the 1st hospital of shijiazhuang and were randomized for treatment either with pfna-ii via the modified trochanteric entry portal and percutaneous technique (group a) with 64 patients (23 males, 41 females) age 77.30±9.52 years or a conventional operative technique (group b) with 53 patients (17 males, 36 females) age 77.66±8.91 years.All patients underwent follow-up assessments at 1, 3, 6, 12 and 24 months after surgery.The mean follow-up time was 26.9 months.The following complications were reported: 7 cases of poor reduction in group a.9 cases of poor reduction in group b.Distance of zero to the lateral cortex on the anteroposterior view defined as impingement.The distance to the lateral cortex as greater than zero (53 in group a) the distance to the lateral cortex as greater than zero (35 in group b) in group b, 2 iatrogenic lateral proximal fractures occurred during the pfna-ii insertion process.2 blade cutouts requiring revision surgery occurred in group b.This report is for an unknown synthes pfna-ii.This report is for (1) unk - constructs: pfna-ii.This report is 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12328563
• MDR Text Key: 267262176
• Report Number: 8030965-2021-06710
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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: 07/19/2021
• 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