MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; SCREW, FIXATION, BONE

Device Problems Material Deformation (2976); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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.This report is for an unknown elastic nails: titanium /unknown lot.Part and lot numbers 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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: james d, et al.(2021), elastic stable intramedullary nailing versus submuscular plating in pediatric diaphyseal femur fractures: a randomized controlled trial among children in south india, journal of pediatric orthopaedics b 2022, 31:e122¿e129 (india).This study was conducted to analyze the hypothesis that elastic stable intramedullary nailing has less adverse events, better outcome and is cost-effective compared to submuscular bridge plating in pediatric femoral diaphyseal fractures.Between october 01, 2013, to may 31, 2016, 40 children (age range 6-15 years) treated for acute, closed, femur diaphyseal length stable fractures were included in the study.The children were randomized into 2 groups of treatment performed; the submuscular bridge plating group (smp) and the elastic stable intramedullary nailing group (esin).The smp group was comprised of 20 children (13 males and 7 females, mean age 10.2 years) who underwent bridge fixation using a competitor¿s sub-vastus locking compression plate (manufacturer: sharma surgical).The esin group was comprised of 20 children (13 males and 7 females, mean age 9.45 years) who underwent fixation using 2 equal diameters of the unknown synthes titanium elastic nails.All children had follow-ups at 2, 6, and 12 months postoperatively.Complications were reported as follows: a 15-year-old girl child, who weighed 35 kg and underwent fixation with (2) 2.5 mm titanium elastic nails, had an implant failure.The nails were revised to 3.0 mm after she developed 30 degrees of sagittal malreduction 2 months after the index surgery.Subsequent fracture union was uneventful and 1.5 cm limb shortening was successfully managed with height correction footwear.An 11-year-old boy who weighed 20 kg and underwent fixation with (2) 2.5 mm titanium elastic nails, had an implant failure.He had 15 degrees of sagittal angulation with a bent implant.The nails went on to uneventful union after augmentation with a plaster cast.2 patients had painful prominent hardware over titanium elastic nails insertion site.Early implant exit was done in all these cases at 6¿9 months postoperatively.1 patient had genu valgum.A copy of the clinical evaluation form is being submitted with this regulatory report.This report involves one unk - elastic nails: titanium.This is report 2 of 3 for pc-001274351.

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: SCREW, FIXATION, BONE
• 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: 16265369
• MDR Text Key: 308392259
• Report Number: 8030965-2023-01135
• Device Sequence Number: 1
• Product Code: HWC
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• 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: 01/10/2023
• 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
• Patient Age: 15 YR
• Patient Sex: Male