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

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna construct/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: yoo, j., chang, j., park,c., hwang, j.(2020), risk factors associated with failure of cephalomedullary nail fixation in the treatment of trochanteric hip fractures, clinics in orthopedic surgery, vol.12, pages 29-36 (south korea).The aim of this study is to present fixation failures after im nailing in elderly patients with trochanteric fractures and compared the failure group with non-failure group to identify risk factors of fixation failure.Between january 20212 and august 2016, a total of 194 patients with trochanteric fractures underwent im nailing.There were 42 males and 141 females with a mean age of 76 years in the non-failure group while there were 11 females on the failure group with a mean age of 76.3 years.Implants used were a nail with a thread-type lag screw was used in 140 patients (itst, trochanteric/subtrochanteric fixation system, zimmer, (b)(4), usa or gamma 3 nail, stryker, (b)(4)), whereas the helical blade-type nail was used in 54 patients (proximal femoral nail anti-rotation; ao synthes, (b)(4)).The article did not specify which of the devices were being used to capture the following complications: 202 patients were excluded due to death during follow-up, bedridden status before injury, and loss to follow-up.An (b)(6) year-old female patient fell on the ground.The proximal fragment was short and varus angulated before surgery.The fracture was reduced by the proximal femoral nail anti-rotation.The lag screw was cutting through at 3 months after surgery.Conversion to hemiarthroplasty with wiring was performed.1 female patient had cut-through of the helical blade.1 female patient had a nail breakage.On fracture reduction, one of the 11 patients showed discontinuity of the medial cortex, but eight patients showed discontinuity of the anterior cortex, thus not achieving anatomical reduction.Cut-out of the thread-type lag screw occurred in 8 patients (not synthes).This report is for an unknown synthes pfna construct.It captures the reported events of not achieving anatomical reduction and implant failure.This is report 6 of 6 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• 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: 11488247
• MDR Text Key: 250009920
• Report Number: 8030965-2021-01976
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: 02/15/2021
• 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