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

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

Patient Problems Paralysis (1997); Pseudoaneurysm (2605); No Code Available (3191)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown expert tibia nail system / quantity: one / unknown lot.Additional device product code: hwc.Udi: unknown part number, udi is unavailable.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.Patient pertains to paresthesia of the dorsal foot, impaired dorsiflexion and revision surgery.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, greve, et al.(2016) pseudoaneurysm of the anterior tibial artery after interlocking tibial nailing: an unexpected complication.Eur j med res, 21, 1-6.The authors reported a case study of a (b)(6) male patient who developed an anterior tibial pseudoaneurysm after tibial nailing with expert tibia nail (synthes, switzerland) to treat a right tibial fracture.In addition to the nail, two proximal medial¿lateral, two distal medial¿lateral, and one distal anterior¿posterior interlocking screws were inserted.Six weeks after surgery, the patient was hospitalized with intermittent edema of the proximal lateral lower leg.Deep vein thrombosis and compartment syndrome were ruled out.A distal interlocking screw was removed due to its close proximity to the distal tibial¿fibular joint.The patient was discharged and readmitted four weeks later due to similar symptoms.A computed tomography (ct) scan revealed a pseudoaneurysm of the anterior tibial artery in close proximity to the level of the proximal interlocking screw insertion.The patient underwent vascular repair and fracture reduction of the fibula.He was revised to standard ao/asif plating.Intraoperatively, the peroneal nerve was affected, resulting in proximal peroneal paralysis with paresthesia of the dorsal foot and impaired dorsiflexion.One year after the initial fracture, the tibial nail was removed and the function of the peroneal nerve had recovered completely.This is report 2 of 2 for (b)(4).This serious injury report is for an unknown expert tibia nail system and pertains to pseudoaneurysm of the anterior tibial artery in close proximity to the level of the proximal interlocking screw insertion with revision surgery; proximal peroneal paralysis with paresthesia of the dorsal foot and impaired dorsiflexion; and explant of the tibial nail.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6349606
• MDR Text Key: 68036081
• Report Number: 2520274-2017-10563
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• 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: 02/02/2017
• 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: 28 YR