MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.410

Device Problem Break (1069)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Additional classification code: hrs and hwc exact implant date is unknown. It occurred in (b)(6) 2017. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). A review of the device history records has been requested. 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.

Event Description

It was reported that a patient was treated for an orif (open reduction internal fixation) of a distal femur. On an unknown date, the plate was found to be broken, and it was discovered that the patient had developed a non-union, which reportedly led to the removing of the broken hardware. On (b)(6) 2017, the patient returned to the operating to remove broken plate, four (4) intact proximal screws and five (5) intact distal screws. The patient was revised to another plate and screw fixation with bone graft. There was no reported surgical delay, no fragments left in the patient, no additional medical or surgical intervention. The procedure was successfully complete, and the patient was stable during and following the surgery. Concomitant devices: unknown 4. 5 cortex screw ss (part # unknown, lot # unknown, qty. 1); unknown 5. 0 variable angle locking screws ss (part # unknown, lot # unknown, qty. 8). This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 02. 124. 410, lot# l377249. Manufacturing location: (b)(4), release to warehouse date: apr 20, 2017. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. It is unknown if the device was reprocessed and reused on patient. Therapy date is unknown date in (b)(6) 2017. 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. Device is a single use device but was not reprocessed or reused. 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/10 HOLE/230MM/RIGHT
• 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 ; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7077160
• MDR Text Key: 93555526
• Report Number: 8030965-2017-50245
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042811
• UDI-Public: (01)10886982042811(10)L377249
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 02.124.410
• Device Catalogue Number: 02.124.410
• Device Lot Number: L377249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/01/2017 Patient Sequence Number: 1