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

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

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Lechler, p and ¿et all¿.(2016).Surgical complications following (esin) for clavicular mid-shaft fractures do not limit functional or patient-perceived outcome.Injury, int.J.Care injured 47, 899¿903.This report is for unknown titanium elastic nails (ten) /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.(other number) udi: unknown part number, udi is unavailable.(b)(4).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 lechler, p and ¿et all¿.(2016).Surgical complications following (esin) for clavicular mid-shaft fractures do not limit functional or patient-perceived outcome.Injury, int.J.Care injured 47, 899¿903.The present retrospective single-centre study aimed to analyse the complications following elastic intramedullary nailing (esin) in adult patients with clavicular mid shaft fractures and their impact on functional and patient-perceived outcome measures.Results were compared to a control group receiving locking plate osteosynthesis.Patients were assigned to group a (esin), using titanium elastic nails (ten) and group b (plate fixation).A total of 47 (33 male, 14 female) operatively managed patients with a mean age of 26.7 (+/-)14.9 years and a follow up time of 38.1 (+/-) 19.4 months were analysed.36 patients were treated by esin (group a), whereas 11 patients received open reduction and internal plate fixation (group b).Patients were operatively treated with a mean delay of 7.4 (+/-) 9.3 days (group a: 6.6 (+/-) 8.7 days, group b: 10.2 (+/-) 11.1 days, p = 0.326) between trauma and the surgical index procedure.The average follow-up time was 38.1 (+/-) 19.4 month (group a: 37.2 (+/-)17.9 months, group b: 40.5 _ 24.7 months, p = 0.655).It was concluded that, despite a relevant incidence of surgical complications, (esin) provides good to excellent functional and patient-perceived results in the treatment of clavicular mid-shaft fractures.This is report 2 of 3 for (b)(4).This report is for an unknown titanium elastic nails (ten) and refers to following adverse events: non-union was recorded in three patients.Implant removal and osteosynthesis by open reposition and internal plate fixation were performed in 2 cases.Reosteosynthesis resulted in osseous healing in all cases.In one asymptomatic patient presenting with a nonunion 27 weeks following (esin), no revision surgery was performed.Surgical complications were noted in 12 patients.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5883541
• MDR Text Key: 52338041
• Report Number: 2520274-2016-14172
• Device Sequence Number: 1
• Product Code: JDS
• 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: 07/27/2016

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?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/17/2016
• 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