MAUDE Adverse Event Report: SYNTHES GMBH UNK - KITS/SETS: FNS IMPLANT KIT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

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

Patient Problems Necrosis (1971); Non-union Bone Fracture (2369); Physical Asymmetry (4573)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

Additional narrative: event date: exact date of event is unknown; (b)(6) 2021 is the date the literature article was published.510k: this report is for an unknown fns implant kit/unknown lot.Part and lot number 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.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: tang y, et al.(2021), femoral neck system versus inverted cannulated cancellous screw for the treatment of femoral neck fractures in adults: a preliminary comparative study, journal of orthopaedic surgery and research, volume 16, number 504, pages 1-8, (china).The present study aimed to compare the short-term outcomes between the femoral neck system group and inverted cannulated cancellous screw group for femoral neck fractures.Between june 2019 and january 2020, 92 patients with femoral neck fractures who underwent femoral neck system or inverted cannulated cancellous screw internal fixation were included in the study.47 patients (34 males and 13 females, mean age 57.4+/-15.0) underwent fixation using the unknown synthes femoral synthes while 45 patients (37 males/8 females, mean age 54.8+/-11.7) underwent fixation with a competitor¿s inverted cannulated cancellous screws.Postoperatively, patients with stable fractures were allowed partial weight-bearing on the second day.Meanwhile, patients with unstable fractures were allowed to undergo isometric contraction exercises of the quadriceps of the femoris and active and passive flexion and extension training of the ankle joint to reduce oedema of the lower extremities.All patients were required to return to the outpatient clinic for follow-up at 1, 3, 6, 9, and 12 months postoperatively and then once every 6 months thereafter.Follow-up ranged from 14 to 24 months.Complications were reported as follows: 11 patients had moderate femoral neck shortening.2 patients had severe femoral neck shortening.2 patients had nonunion.1 patient had osteonecrosis.3 patients had screw-out.This report is for an unknown femoral neck system (fns) implant kit.This is report 1 of 2 for (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.

• Brand Name: UNK - KITS/SETS: FNS IMPLANT KIT
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14435500
• MDR Text Key: 292023106
• Report Number: 8030965-2022-03299
• Device Sequence Number: 1
• Product Code: KTT
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• 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: 04/20/2022
• 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