MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.415
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: hrs, hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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 the patient underwent revision due to non-union of the distal femur fracture and the variable angle (va) locking compression (lcp) curved condylar plate was broken.The fracture had to be revised with plate and screws.There are broken screws.It was unknown if there was a surgical delay and as well as the patient outcome.No other additional information provided.Concomitant device reported: unknown screws (part# unknown, lot # unknown, quantity unknown) this complaint involves one (1) device.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Event description updated, concomitant devices reported are not concomitant and have been included as impacted product in this complaint.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 the patient underwent revision due to non-union of the distal femur fracture and the variable angle (va) locking compression (lcp) curved condylar plate and screws were broken.The fracture had to be revised with plate and screws.It was unknown if there was a surgical delay and as well as the patient outcome.The patient was implanted with a competitor's plate, original implant date is unknown, surgery was successfully completed.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part 02.124.415, lot 8949665: manufacturing site: mezzovico.Release to warehouse date: april 25, 2014.No non-conformance reports (ncrs) were generated during production.Review of the device history record 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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/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: 7529665
• Report Number: 2939274-2018-52216
• Device Sequence Number: 1422214
• Product Code: JDP
• UDI-Device Identifier: 10886982042910
• UDI-Public: (01)10886982042910
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2018

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: 02.124.415
• Device Catalogue Number: 02.124.415
• Device Lot Number: 8949665
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 05/17/2018; 06/11/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 05/22/2018; 06/11/2018
• 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