MAUDE Adverse Event Report: SYNTHES USA 4.5MM LCP® CURVED CONDYLAR PLATE 14 HOLES/314MM-LEFT; APPLIANCE FIXATION NAIL

Catalog Number 02.001.304

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery for a distal femur fracture.The broken plate was taken out along with the screws which were all intact.A new plate with new screws was implanted.There was no time delay and the surgery was successfully completed.The patient outcome was reported as good.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Date of original implant is unknown.It is unknown whether or not the facility will be returning the complainant part.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM LCP® CURVED CONDYLAR PLATE 14 HOLES/314MM-LEFT
• Type of Device: APPLIANCE FIXATION NAIL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4381169
• MDR Text Key: 5240580
• Report Number: 2520274-2015-10053
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK041911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.001.304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• 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