MAUDE Adverse Event Report: SYNTHES (USA) 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.412

Device Problem Break (1069)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Event Description

It was reported that a patient had x-rays performed on (b)(6) 2014 which revealed a non-union of the right femur and a broken 10 hole, variable angle locking condylar plate (valcp).The plate was broke between the screws in the shaft and distal cluster of screws on the head of the plate.A revision surgery was performed on an unknown date.The plate was broken at a screw hole but there was no screw in the hole.No device allegation against any of the screws.The procedure was completed successfully with no surgical delay.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Event date: date unknown.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.Device was 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.

Manufacturer Narrative

Device was 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.

Event Description

It was reported that a patient had x-rays performed on (b)(6), 2013 which revealed non-union of the right femur and a broken 12 hole, variable angle locking condylar plate (valcp).The plate was broke between the screws in the shaft and distal cluster of screws on the head of the plate.A revision surgery was performed on an unknown date.The plate was broken at a screw hole but there was no screw in the hole.No device allegation against any of the screws.The procedure was completed successfully with no surgical delay.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was 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 VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT
• 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: 4250757
• MDR Text Key: 18797218
• Report Number: 2520274-2014-14739
• 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,Followup,Followup
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2014
• 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