MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.419

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event occurred on an unknown date in 2020.Additional procode: hrs, hwc.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that on (b)(6) 2020, the condylar plate was broken.The original date of implantation was in (b)(6) of 2020.A new plate was implanted successfully.The broken fragments were removed easily without any medical intervention.The procedure was successfully completed.The patient was stable after the procedure.Concomitant devices reported: unknown screws (part# unknown, lot# unknown, quantity# 10).This report is for 1 4.5mm va-lcp curved condylar plate/18 hole/370mm/left.This is report 1 of 1 for (b)(4).

Event Description

Concomitant devices: 5.0mm variable angle lockng screw / slf-tpng / strdrv / 80mm (part#: 02.231.280, lot#: 37p4273, quantity#: 1).5.0mm variable angle lockng screw / slf-tpng / strdrv / 85mm (part#: 02.231.285, lot#: 25p0999, quantity#: 2).5.0mm variable angle lockng screw / slf-tpng / strdrv / 90mm (part#: 02.231.290, lot#: 32p5900, quantity#: 3).Unknown screws (part#: unknown, lot#: unknown, quantity#: 2).5.0mm periprosthetic va lckng screw / slf-tpng / strdrv / 16mm (part#: 02.231.016, lot#: 24p3654, quantity#: 1).5.0mm periprosthetic va lckng screw / slf-tpng / strdrv / 14mm (part#: 02.231.014, lot#: 26p3576, quantity#: 1).

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.H3, h6: part number: 02.124.419, synthes lot number: 28p7304, manufacturing site: mezzovico, release to warehouse date: 02 dec 2019.A manufacturing record evaluation was performed for the not sterile device lot number, and no non-conformances were identified.Visual inspection: the 4.5mm va-lcp curved condylar plate / 18 hole / 370mm / left (p/n: 02.124.419, lot number: 28p7304) was received at us customer quality (cq).Visual inspection of the complaint device showed the plate had broken at the 8th combi hole.Two unknown screws were screwed into the plate as well.There was no allegation against these screws, and no issues, damage, or defects were observed.Therefore, these screws will remain concomitant devices.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the plate has broken at the 8th combi hole.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and / or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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/18 HOLE/370MM/LEFT
• Type of Device: 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: 10308889
• MDR Text Key: 199893329
• Report Number: 2939274-2020-03257
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042996
• UDI-Public: (01)10886982042996
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.419
• Device Catalogue Number: 02.124.419
• Device Lot Number: 28P7304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Date Manufacturer Received: 07/31/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Age: 48 YR