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

Model Number	02.124.410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id/initials, age/date of birth and weight are unknown additional product codes: hrs, hwc.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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 open reduction internal fixation (orif) surgery of the femur plate and unknown screws due to a non-union of a femur fracture resulting to a broken 4.5mm variable angle-locking compression plate curved condylar plate right.The plate and screws were replaced during the procedure on an unknown date.The patient was originally implanted with a femoral plate and unknown screws on the right femur.Original implant date was unknown.It was unknown if there was a surgical delay.Patient outcome was unknown.Concomitant device reported: variable angle locking screws (part/lot unknown, quantity unknown); 4.5 cortex screws (part/lot unknown quantity unknown).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 history record (dhr) review: part no: 02.124.410; lot no: l377248; manufacturing location: (b)(4); release to warehouse date: april 20, 2017.The plate was made from forging blank: 60067383, lot no: l371427 which was made from smb medical sa.Release to warehouse date: march 24, 2017.No nonconformance records (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.Investigation summary: investigation flow: broken.Visual inspection: visual inspection performed at customer quality (cq) confirmed the condition of post operative plate breakage, which agrees with the reported complaint condition.The plate was received at cq in two pieces.A transverse break mid combi hole exists.Additionally, a transverse crack at an adjacent combi hole also exists.The material surface at the fracture sites appear homogeneous when viewed under 10x magnification at cq.Document/specification review: the returned device was manufactured in april 2017.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.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Tabulated product drawing for the family of va lcp curved condylar plates was reviewed during this investigation.No product design issues or discrepancies were observed.Dimensional inspection: the width of the returned plate near breakage measured 17.84mm at cq (ca592) which is within specification of 17.5mm +0.5/-0.1mm per device drawing.The middle thickness of the returned plate near breakage measured 5.80mm at cq (ca592) which is within specification of 5.4mm +0.4/-0 mm per device drawing.Conclusion: a definitive root cause for the post operative plate breakage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation and the complaint is adequately addressed by the risk assessment.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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/10 HOLE/230MM/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: 7610671
• Report Number: 2939274-2018-52526
• Device Sequence Number: 13864419
• Product Code: JDP
• UDI-Device Identifier: 10886982042811
• UDI-Public: (01)10886982042811
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 05/22/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.124.410
• Device Catalogue Number: 02.124.410
• Device Lot Number: L377248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/18/2018
• 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