MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

Device Problem Material Distortion (2977)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Song, m.And et al.Percutaneous epiphysiodesis using transphyseal screws in the management of leg length discrepancy: optimal operation timing and techniques to avoid complications.J pediatr orthop volume 35, number 1, 89-93.This report is for unknown - cannulated screw/unknown quantity/unknown lot.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.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 subsequent review of the following literature article song, m., and et al.(2015) percutaneous epiphysiodesis using transphyseal screws in the management of leg length discrepancy: optimal operation timing and techniques to avoid complications.J pediatr orthop volume 35, number 1, 89-93.The purpose of this article is to analyze effects of percutaneous epiphysiodesis using transphyseal screws (pets) on leg length discrepancy (lld), its associated complications, to determine optimal operation timing, and find ways of preventing complications.Fifty-nine patients (36 boys and 23 girls) were enrolled in this retrospective study.Age at operation was 13.7 years (range, 11.3 to 15.0 y) for boys and 11.8 years (range, 10.7 to 12.6 y) for girls, and patients were followed up for a mean 3.9 years (range, 2.2 to 7.7 y).Complications: fourteen unknown patients had undercorrection and one unknown patient had overcorrection.It cannot be determined whether the serious injury was with a synthes or a competitor's implant.Unknown number of patient(s) had two screws that broke at the threaded portion, which were stuck at the cortex, and were left behind.It cannot be determined whether or not the screw that broke was a synthes or a competitor's implant.Unknown number of patient(s) had small heads of two cannulated screws (synthes) were distorted during removal, failing to endure the torque of screwdriver, and were left in situ.This is report 3 of 3 for (b)(4).This report is for an unknown - cannulated screw and refers to unknown number of patient(s) who had small heads of two cannulated screws (synthes) were distorted during removal, failing to endure the torque of screwdriver, and were left in situ.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5188477
• MDR Text Key: 29880579
• Report Number: 2520274-2015-16909
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 10/29/2015
• 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