MAUDE Adverse Event Report: SYNTHES USA; WIRE, SURGICAL

Device Problem Sticking (1597)

Patient Problem Sedation (2368)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article.Surgical treatment of distal radial fractures with a volar locking plate versus conventional percutaneous methods.Alexia karantana, frcs(orth), nicholas d.Downing, frcs(orth), daren p.Forward, frcs(orth), dm, mark hatton, frcs(orth), andrew m.Taylor, frcs(orth), dm, brigitte e.Scammell, frcs(orth), dm, chris g.Moran, frcs(ed), dm, and tim r.C.Davis, frcs.J bone joint surg am.2013;95:1737-44.A single-center, pragmatic, randomized controlled trial was conducted in a tertiary care institution.One hundred and thirty patients (eighteen to seventy-three years of age) who had a displaced distal radial fracture were randomized to treatment with either a volar locking plate or a conventional percutaneous fixation method.Instrumentation used in the control group included smooth 1.6-mm kirschner wires and a supplemental standard ao/asif external fixator (synthes, (b)(4)), for 67 patients.The percutaneous kirschner wires became inadvertently buried in six patients, requiring removal with use of a local anesthetic.One patient who developed carpal tunnel syndrome three months following injury required median-nerve decompression.Another patient sustained an extensor pollicis longus rupture and later required reconstruction.He had been randomized to the control group but underwent volar locking plate fixation at his surgeon¿s discretion, after use of kirschner wires failed to achieve an acceptable intraoperative result.This report is for unknown k-wires for buried k-wires in 6 patients.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Surgical treatment of distal radial fractures with a volar locking plate versus conventional percutaneous methods.J bone joint surg am.2013;95:1737-44.This report is for unknown wires.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.

• 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: 3816291
• MDR Text Key: 16804996
• Report Number: 2520274-2014-11352
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• 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?: Yes
• Date Manufacturer Received: 04/26/2014
• 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