MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.417

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product codes: hrs, hwc.Lot number unavailable.Implant and explant dates unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 on an unknown date, the patient underwent a revision surgery due to a non-union fracture in the distal femur.The variable angle (va)-locking compression plate (lcp) curved condylar plate broke at the fracture site and was removed.A new plate was placed along the distal femur along with a retrograde femoral nail in canal.It is unknown if there was a surgical delay.Patient outcome is unknown.Concomitant device/s reported: unknown locking screws (part# unknown, lot# unknown, quantity# unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7866029
• MDR Text Key: 119873753
• Report Number: 2939274-2018-53701
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042958
• UDI-Public: (01)10886982042958
• 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: Physician
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.417
• Device Catalogue Number: 02.124.417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 87