MAUDE Adverse Event Report: SYNTHES GMBH UNK - CABLE/WIRE; WIRE, SURGICAL

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

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Non-union Bone Fracture (2369); Ambulation Difficulties (2544); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: pachore, j., shah, v.I., upadhyay, s., and patel, s.B.(2023) primary arthroplasty for unstable and failed intertrochanteric fractures: role of multi-planar trochanteric wiring technique, hip pelvis, vol.35 ( 2 ) : pages 108-121 ( india ).The primary aim of this study was to demonstrate the trochanteric wiring technique.A secondary objective was to evaluate the clinic -radiological outcomes of use of the wiring technique during primary arthroplasty for treatment of unstable and failed intertrochanteric fractures.Between january 2018 to september 2020, 127 patients with unstable intertrochanteric fracture of the femur (types of ao type 31-a2.2, a2.3, and a3) and failed intertrochanteric fractures ( n=35 ) using dhs ( dynamic hip screw ) who underwent primary hip arthroplasty using novel multi-planar trochanteric were included in the study.The study included 71 female patients (55.9%) and 56 male patients (44.1%) with a mean age of 71.1±3.0 years (range, 60-81 years).A total of 77 patients (60.6%) underwent hemi arthroplasty and 50 patients (39.4%) underwent total hip replacement.The proposed technique involves steps.First, a vertical wire loop configuration (ao 20-gauge) was used to anchor the trochanter to avoid damage and tightened the gluteus medius.The mean follow-up period was 17.8±4.7 months (range, 12 to 24 months) and the minimum follow-up period was 12 months.The following complications were reported as follows : - 18 patients had failed intertrochanteric fracture and underwent primary hip arthroplasty using novel multi-planar trochanteric wiring.- 1 patient ( 0.8 % ) had nonunion in fractured.The patient had a history of trauma three months after the index surgery.The patient walked with a lurch and does not want to undergo any further work up/surgical intervention.- 3 patients ( 2.4 % ) had wire breakage ; however, healing was not impaired, and the trochanter was stable.This finding demonstrates that one of the systems remains intact and enables bone healing.Even with breakage of one vertical wire loop the other wire can hold the trochanter, which may encourage union.- 5 patients (3.9%) had lld ( limb length discrepancy ).Two patients had a discrepancy of 1 cm, and three patients had a discrepancy of 0.5 cm.- 3 patients (2.4%) reported with a lurch.- 3 patients ( 2.4 % ) were reported wire related bursitis such as pain and swelling.Two of these patients received conservative treatment and one of them required removal of hardware.This is for an unknown synthes cable/wire.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4-510k: this report is for an unknown cable/wires/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Brand Name: UNK - CABLE/WIRE
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18545592
• MDR Text Key: 333291064
• Report Number: 8030965-2024-01096
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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: 01/03/2024
• 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