MAUDE Adverse Event Report: SYNTHES USA 5.0MM CANNULATED VA LOCKING SCREW/75MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.675

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to the non-union of a fracture.On (b)(6), 2013, the patient was treated for a distal femur fracture with one 4.5mm variable angle locking compression plate (va-lcp) curved condylar plate, two cortex screws and ten locking screws.The patient returned on (b)(6), 2014 to have the 4.5mm va-lcp curved condylar plate removed due to a non-union of the fracture and to revise it with a retrograde/antegrade femoral nail (rafn).The plate and eleven of the screws were removed without any issues.One 68mm long, 4.5mm cortex screw self-tapping was found to be broken at the head of the screw, but was easily removed using locking pliers.This delayed the surgery no more than 5 minutes.All other implanted devices were removed and the surgeon performed the revision by implanting the rafn in the patient.The procedure was completed successfully with no patient harm reported.This report is 8 of 13 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code for this report includes; hrs and hwc.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM CANNULATED VA LOCKING SCREW/75MM
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• 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: 4054821
• MDR Text Key: 4905675
• Report Number: 2520274-2014-13409
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2014
• 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
• Patient Weight: 76