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

Device Problem Bent (1059)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment not diagnosis.Porat, s., simanovsky, n., simanovsky, n., tair, m.Removal of flexible titanium nails in children (2006) j pediatr orthop, vol 26, no 2, pp:188-192.This report is for an unknown flexible titanium nail.(other number) udi: unknown part number, udi is unavailable.(b)(4).Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were 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 journal article: porat, s., simanovsky, n., simanovsky, n., tair, m.Removal of flexible titanium nails in children (2006) j pediatr orthop, vol 26, no 2, pp:188-192.This study analyzed the removal of one specific type of implant: flexible titanium nails (embrochage centro-medullaire elastique stable; depuy int., (b)(4)), used for diaphyseal fractures of the femur or forearm bones, which are often treated with titanium flexible nails.The purpose of this study was to analyze the indications for this procedure and its complications, and to discuss its justification.Medical records and radiographs of 143 children who underwent flexible titanium nail removal between 1998 and 2002 were retrospectively reviewed.Patient age ranged from 4 to 17 years.Data were collected regarding the indication for fixation, the time from fixation to nail removal, the difficulty of nail removal, the operative time, and intraoperative and postoperative complications.A (b)(6) boy who underwent a fracture reduction and fixation with a titanium nail.Two (2) months later the boy showed clinical and radiographic healing, however was hit by a car and had suffered refracture with nails bending.One (1) month later he underwent closed reduction of refracture and exchange of the nails.A (b)(6) boy who had two refractures of the diaphyses of the radius and ulna for two separate incidents of falling down while playing basketball was treated and suffered from refracture with nails in situ as a result of falling down again while playing basketball.This time we failed to retrieve the nails due to the very strong bonding, and he was treated with open reduction of the fractures and compressive plating of both bones.The second patient from the forearm group was a (b)(6) boy in whom we failed to retrieve the nails after a refracture, 3 years after the initial treatment of the fractures.In another case, nonelective nail removal was performed due to a nonunion of the diaphyseal fracture of the ulna.The nails were removed and the fracture was treated by compression plating, and it healed well.In 139 patients, elective removal of the nails was scheduled when sound healing of the fracture was confirmed by two-plane radiographs.Nail protrusion under the skin and pain or discomfort were the indications for nail removal in 12 children (13%) in the femoral group and in 4 children (8%) in the forearm group.This report is for an unknown flexible titanium nail.This is report 1 of 4 for (b)(4).This medwatch will address the (b)(6) boy who underwent a fracture reduction and fixation with a titanium nail.Two (2) months later the boy showed clinical and radiographic healing, however was hit by a car and had suffered refracture with nails bending.One (1) month later he underwent closed reduction of refracture and exchange of the nails.

• 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: 5833381
• MDR Text Key: 50750743
• Report Number: 2520274-2016-13713
• 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
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• 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?: No
• Date Manufacturer Received: 07/27/2016
• 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
• Patient Age: 12 YR