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

Device Problem Migration (4003)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown pfna short construct/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between (b)(6) 2010 and (b)(6) 2012.Complainant part is not expected to be returned for manufacturer review/investigation.Fax number: (b)(6).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: helin, m.Et al.(2015), does the pfna nail limit impaction in unstable intertrochanteric femoral fracture? a 115 case-control series, orthopaedics & traumatology: surgery & research, vol 101, pages 45-49 (france).The objectives of this study were: to validate the ender classification to assess fracture stability; to determine whether neck shortening, and head purchase quality varied with stability; and to determine the functional impact of femoral neck shortening.Between september 2010 and september 2012, patients underwent fracture fixation used the titanium pfna nail (synthes, etu-pes, france).The patients were divided into 2; 45 patients under unstable fractures and 70 patients under stable fractures.The following complications were reported: 8 patients died.An (b)(6) year-old female patient had an early disassembly with fracture impaction and blade cut-out from the femoral head.1 patient had simple lavage for surgery site infection.2 patients had disassembly for mechanical reasons (cut-out or cut-through) requiring revision by total hip replacement within 3 months.This report is for an unknown synthes pfna.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA SHORT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 12341930
• MDR Text Key: 267251539
• Report Number: 8030965-2021-06832
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 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?: Yes
• 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