MAUDE Adverse Event Report: SYNTHES (USA); WIRE, SURGICAL

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article.Salonen, a., salonen, h., & pajulo, o.(2012).A critical analysis of postoperative complications of antebrachium ten-nailing in 35 children.Scandinavian journal of surgery, 101, 216-221.Unstable antebrachium diaphyseal fractures in children are increasingly being treated by elastic intramedullary nailing (ten).This study was done to assess both radiological and functional outcome of antebrachium fractures treated by titanium elastic nail (ten) in pediatric children.From january 2001 to december 2005 35 children were treated by titanium elastic nailing (ten).Of the 35 children 20 were boys and 15 were girls.There were 23 patients that achieved healing of the fractures without any limitation to range of motion.Although different minor complications, titanium elastic nails (ten) is considered a treatment for unstable forearm fractures shaft fractures.Twenty four of the forearm fractures were instable, five were open, five were re-fractures and one had ulnar nerve deficit.In all but one patient both forearm bones were fractured.Twelve (34 percent) operations were managed by closed reduction, open reduction was needed in 23 (66 percent) patients.In 29 cases both bones were fixed with titanium elastic nail (ten).In the four patients with re-fracture in both ulna and radius only the radius was titanium elastic nail.In one case radius was fixed with titanium elastic nail (ten) and ulna with kirschner (k-wire) and in another case radius was fixed with titanium elastic nail (ten) and ulna with plate.One patient with fracture was treated by open reduction.The ulna was fixed with a ten-nail and the radius was fixed dorsally with a single kirschner-wire.Before the operation a partial ulnar nerve deficit was noted and postoperatively the ongoing pain over the ulnar nerve distribution was reported by the patient.In the first control visit the flexor contracture was noted, which led to a referral to the hand surgeons and a volkmann¿s ischemic contracture was diagnosed.Consequently, the osteosynthesis material was removed by the hand surgeons concurrently with a flexor release operation ten weeks after the primary operation.During the follow up time the patient recovered fully.Three patients with long-term complications had pain caused by ulnar ten-nail.In one patient 12 degree volar angulation and protruding ulnar nail were noted five weeks after operation.The nail was removed and the patient wore a daytime short arm cast afterwards.In follow up controls there was delayed fracture union.One patient¿s radius was ten-nailed and ulna was plated.During the follow-up controls ulna was poorly united.The re-fracture was treated by plating both.During the follow-up period time all these patients recovered well and the functional outcome was good, including the patient with volkmann¿s contracture.Most of the problems were due to poor technical performance in the nailing.This report is for 1 device.This is for an unknown kirschner wire.Not sufficient information to file multiple reports.Four of 4 medwatches.

Manufacturer Narrative

Device is used for treatment not diagnosis.Salonen, a., salonen, h., & pajulo, o.(2012).A critical analysis of postoperative complications of antebrachium ten-nailing in 35 children.Scandinavian journal of surgery, 101, 216-221.This report is for an unknown kirschner wire.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: WIRE, SURGICAL
• 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: 3786055
• MDR Text Key: 16551597
• Report Number: 2520274-2014-10932
• Device Sequence Number: 1
• Product Code: LRN
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention