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	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: event occurred on an unknown date in 2019.Additional product codes: hrs, hwc.(b)(4).Device evaluated by mfr, manufacture date, event problem and evaluation codes: device history lot: part: 02.124.412, lot: l824012, manufacturing site: (b)(4), release to warehouse date: 20.Mar.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate (b)(4) was reviewed and the used material was according to specification for implants for surgery.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 removal of plate and screws on (b)(6) 2019, due to broken variable angle (va) locking compression plate (lcp) curved condylar right side at the 6th and 7th hole of the shaft of the plate.The patient has an original implant of nine (9) unknown locking screws and two (2) unknown cortex screws on (b)(6) 2019.The patient had been walking on it against the surgeons direction, and a partial weight bearing plate broke.All the implants were removed successfully and the patient was repaired with intramedullary retrograde antegrade femoral nail successfully.There was no surgical delay.Procedure was successfully completed.Patient outcome is unknown.Concomitant devices reported: unk - screws: locking (part# unknown; lot# unknown; quantity 9).Unk - screws: cortex (part# unknown; lot# unknown; quantity 2).This report is for one (1) 4.5mm va-lcp curved condylar plate/12 hole/266mm/right.This is report 1 of 1 for (b)(4).
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.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.
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.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary - product was not returned.Based on the information available, it has been determined that no corrective and/or 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.

• 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: 8432897
• Report Number: 2939274-2019-57022
• Device Sequence Number: 11028527
• Product Code: JDP
• UDI-Device Identifier: 10886982042859
• UDI-Public: (01)10886982042859
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2019

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: 02.124.412
• Device Catalogue Number: 02.124.412
• Device Lot Number: L824012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 03/29/2019; 04/26/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 04/25/2019; 04/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 120