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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional: hrs and hwc.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
It was reported that on an unknown date, the patient underwent removal of the variable angle -locking compression plate (lcp) curved condylar plate.It was discovered as broken due to unknown reasons.The surgeon decided to proceed with a total knee revision.The plate was broken through the non-locking portion of the fifth (5th) hole in the shaft closest to the distal end.The patient had an implant of plate and unknown screws on an unknown date.The screws and plate fragments were removed successfully and easily without additional intervention.Procedure was successfully completed with no surgical delay.Procedure had no adverse effect to the patient.Concomitant device: unknown screws (part#unknown, lot#unknown, quantity, unknown).This report is for one (1) 4.5mm va-lcp curved condylar plate/10 hole/230mm/right.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT
• Common Device Name: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8239535
• Report Number: 2939274-2019-55791
• Device Sequence Number: 1593796
• Product Code: JDP
• UDI-Device Identifier: 10886982042811
• UDI-Public: (01)10886982042811
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.124.410
• Device Catalogue Number: 02.124.410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 57