MAUDE Adverse Event Report: SYNTHES USA 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT; IMPLANT,FIXATION DEVICE,

Catalog Number 02.124.408

Device Problem Break (1069)

Patient Problems Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4) the reporter indicated that there were unanticipated x-rays taken as a result of this event.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 female patient underwent surgery for a right distal femoral fracture on an unknown date.She was seen in the office post surgery for complaints of pain.An x-ray revealed a broken plate which was noted to be broken in two pieces right above the head of the plate.It was also reported that the patient had a nonunion.On (b)(6) 2016, the patient underwent revision surgery for the removal of the plate and an unknown number of intact locking and cortical screws.The patient was revised to the same type of plate and screws.The pieces of the plate were easily removed and there was no delay in surgery.The procedure was completed successfully.This complaint is for one device.Concomitant devices reported: locking and cortical screws (part #unknown, lot #unknown, quantity #unknown).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: this event resulted in pain and required additional intervention to remove the broken plate and revise to another plate and screws.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/8 HOLE/195MM/RIGHT
• Type of Device: IMPLANT,FIXATION DEVICE,
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5777309
• MDR Text Key: 49021965
• Report Number: 2520274-2016-13398
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.408
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention