MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED VA LOCKING SCREW/90MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.231.690

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Unknown event year and date.Additional product code : hrs hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed and no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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 Description

It was reported that on (b)(6) 2021 the patient underwent revision due to malunion of distal femur.There was no surgical delay reported.There were fragments generated and it is unknown if they remove easily without additional intervention.The procedure was successfully completed.The patient outcome was unknown.This complaint involves ten (10) devices.This report is for (1) 5.0mm cannulated va locking screw/90mm.This report is 6 of 10 (b)(4).

• Brand Name: 5.0MM CANNULATED VA LOCKING SCREW/90MM
• 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
• MDR Report Key: 11529235
• MDR Text Key: 241432091
• Report Number: 2939274-2021-01439
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982062932
• UDI-Public: (01)10886982062932
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.231.690
• Device Catalogue Number: 02.231.690
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Patient Sequence Number: 1
• Treatment: 4.5MM VA-LCP CRVD CNDLR PLT/18 HLE/370MM/LFT; 5.0MM CANND VA LKNG SCRW/85MM; 5.0MM CANND VA LKNG SCRW/95MM; 5.0MM CANND VA LKNG SCRW/95MM; 5.0MM CANND VA LKNG SCRW/95MM; 5.0MM VBLE ANGL LKNG SCRW/SLF-TPG/STDR/38MM; 5.0MM VBLE ANGL LKNG SCRW/SLF-TPG/STDR/40MM; 5.0MM VBLE ANGL LKNG SCRW/SLF-TPG/STDR/42MM; 5.0MM VBLE ANGL LKNG SCRW/SLF-TPG/STDR/46MM
• Patient Outcome(s): Required Intervention