MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; IMPLANT,FIXATION DEVICE,CONDYLAR PLATE

Model Number	02.124.412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of non-union is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Dhr review was completed.Part no.: 02.124.412 lot no.: 9764613.Manufacturing location: (b)(4).Release to warehouse date: 17.Dec.2015.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 patient underwent a hardware removal and revision on (b)(6) 2018 due to a nonunion of the right distal femur.Initially, on (b)(6) 2016, patient was implanted with one (1) 4.5mm variable angle ¿ locking compression plate (va-lcp) curved condylar plate/12 hole/266mm/right, four (4) 4.5mm cortex screws, three (3) 5.0 mm locking screws, and six (6) 5.0 mm cannulated screws.All hardware was removed and patient was revised to an intermedullary 13.0 mm by 360.0 mm cannulated femoral nail.Hardware removal and revision were completed successfully with no complication.Patient status was reported as stable.This report is for one (1) 4.5mm va lcp curved condylar plate.(b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/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: 7265300
• Report Number: 2939274-2018-50599
• Device Sequence Number: 19091607
• Product Code: JDP
• UDI-Device Identifier: 10886982042859
• UDI-Public: (01)10886982042859(10)9764613
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2018

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: 02.124.412
• Device Catalogue Number: 02.124.412
• Device Lot Number: 9764613
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 86