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

Device Problem Bent (1059)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Cameron, c., meek, r., blachut, p., o'brien, p.And pate, g.(2014).Intramedullary nailing of the femoral shaft: a prospective, randomized study.J orthop trauma, 28, s11-s14.This report is for an unknown femoral nail/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.(b)(4).

Event Description

This report is being filed after the subsequent review of the following literature article, cameron, c., meek, r., blachut, p., o'brien, p.And pate, g.(2014).Intramedullary nailing of the femoral shaft: a prospective, randomized study.J orthop trauma, 28, s11-s14.The authors conducted a prospective, randomized study on 84 consecutive patients with 88 acute, traumatic femoral shaft fractures using 27 synthes nails, and two other competitor devices.The study was conducted between october 1987 and may 1989.There were 21 women and 63 men with a mean age of 30 years (range, 14-75 years).Post-operatively, the patients were followed up both clinically and radiographically.One patient died from unrelated causes.Historical data were obtained for 70 patients with 74 fractures with a follow-up of 10-31 months (mean, 20 months).Results included the following: a male patient had a second motorcycle accident 14 weeks postoperatively and bent the nail at the site of the initial fracture.He underwent a repeat nailing.The authors did not specify which implant device was used.This is report 6 of 6 for (b)(4).This report is for an unknown femoral nail.

• 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: 5694660
• MDR Text Key: 46398890
• Report Number: 2520274-2016-12950
• 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: foreign,literature,user facil
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• 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