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 Hematoma (1884); Seroma (2069); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown pfna long construct/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between (b)(6) 2015.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: chmielnicki m., prokop a., (2015) pertrochanteric femur fracture - our technique and results, z orthop unfall volume 153, pages 137-140 (germany) doi http://dx.Doi.Org/10.1055/s-1383196.This study aims to demonstrate the operation technique by video and our own results of the last two years.From january 1 to december 31 , 2015 , 210 patients with an average age of 80.7 years with pertrochanteric femur fractures were treated with pfna from synthes.Women were affected in 77% of the cases.The following complications were reported as follows: - four patients died of cardiovascular failure with asa 3 and 4 during the inpatient stay.- hospital mortality in all patients from 2007 to 2011 who underwent surgery for proximal femur fractures in our hospital.1057 patients underwent surgery.722 patients were operated on within the first 24 hours, 209 patients after more than 24-48 hours, and 126 patients > 48 hours after admission.Hospital mortality for surgery on day 1 was 4.1%, 7.2% by day 2, and 8% after 48 hours.-only in the 16 patients operated over 2 hours, 1 death occurred due to intraoperative cardiovascular failure in a 92-year-old female patient.- 1 infection.- 6 hematomas and seromas that were surgically drained.- 6 misplaced implants.- 6 blade migration and cutouts.This report is for an unknown synthes pfna.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown pfna long construct.This is report 1 of 13 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12287916
• MDR Text Key: 265390889
• Report Number: 8030965-2021-06459
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• 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: 07/09/2021
• 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