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

Model Number	02.124.409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code hrs, hwc.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) 2020, the patient underwent a revision procedure to remove the broken variable angle locking compression plate (va-lcp) curved condylar plate and two (2) of the 4.5 mm cortex screws on femur.The patient experienced pain, nonunion and delayed healing.Originally, the patient had an initial surgery last (b)(6) 2018 where the reported devices were implanted.During the revision procedure, all the original implants were successfully removed including the generated fragments from the broken devices.Fragments were removed easily without additional intervention.The patient was revised to a retrograde/ antegrade femoral nail (rafn).The procedure was successfully completed without surgical delay.Patient status was good.Concomitant devices reported: unknown va locking screws, (part # unknown, lot # unknown, quantity 4), unknown va cannulated locking screws, (part # unknown, lot # unknown, quantity 4), unknown cortex screw (part # unknown, lot # unknown, quantity 1).This is report 01 of 03 of (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT
• 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: 9677109
• Report Number: 2939274-2020-00666
• Device Sequence Number: 19500140
• Product Code: JDP
• UDI-Device Identifier: 10886982042798
• UDI-Public: (01)10886982042798
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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: 02.124.409
• Device Catalogue Number: 02.124.409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 5.0 MM CANNULATED; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 72