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

Model Number	02.124.411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown date in 2018.Additional product codes: 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.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 or Problem Description
It was reported that a hardware removal and revision of a variable angle-locking compression plate (va-lcp) curved condylar plate was performed on (b)(6) 2018.The patient was implanted with one (1) va-lcp curved condylar plate, two (2) 5 mm cannulated va locking screws 25 mm, one (1) 5 mm cannulated va locking screws 45 mm, one (1) 5 mm cannulated va locking screws 50 mm, one (1) 5 mm cannulated va locking screws 65 mm, one (1) 5 mm cannulated va locking screws 70 mm, one (1) 4.5 mm cortex screw 36 mm and three (3) 4.5 mm cortex screws 38 mm on (b)(6) 2018.Subsequently, after the procedure, the patient fell and re-broke the femur right above the plate.The patient was brought back to the surgery on (b)(6) 2018, and the surgeon took out the plate and revised it to a new one.All the other implanted devices were also removed along with the plate.The procedure was completed successfully with no surgical delay.No device broke, so no fragments were generated from broken device.No other medical intervention required.Patient outcome was not reported.Concomitant device (s) reported: 5 mm cannulated va locking screws 25 mm (part # 02.231.625, lot # unknown, qty # 2), 5 mm cannulated va locking screws 45 mm (part # 02.231.645, lot # unknown, qty # 1), 5 mm cannulated va locking screws 50 mm (part # 02.231.650, lot # unknown, qty # 1), 5 mm cannulated va locking screws 65 mm (part #02.231.665, lot # unknown, qty #1), 5 mm cannulated va locking screws 70 mm (part # 02.231.670, lot # unknown, qty # 1), 4.5 mm cortex screw 36 mm (part # 214.836, lot # unknown, qty # 1) and 4.5 mm cortex screw 38 mm (part # 214.838, lot # unknown ,qty # 3).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/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: 7641899
• Report Number: 2939274-2018-52648
• Device Sequence Number: 2073859
• Product Code: JDP
• UDI-Device Identifier: 10886982042835
• UDI-Public: (01)10886982042835
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.124.411
• Device Catalogue Number: 02.124.411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/27/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 77