MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT; CONDYLAR PLATE FIXATION IMPLANT

Model Number 02.124.408

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation: initial reporter is synthes sales representative the investigation could not be completed; no conclusion could be drawn, as no product was received.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.Part number: 02.124.408, lot number: 51p2672, manufacturing site: (b)(4), release to warehouse date: april 07th 2020.A manufacturing record evaluation was performed for the non-sterile finished device lot number, and no non-conformances were identified.Device history review part: 02.124.408, lot: 51p2672, manufacturing site: (b)(4), release to warehouse date: april 07th 2020.A manufacturing record evaluation was performed for the non-sterile finished device lot number, and no non-conformances were identified.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 an unknown date, the devices were discovered as damaged after the sales consultant received the item shipments.Multiple packages were broken with the screws reported as flattened.There was no patient involvement.This report is for one (1) 4.5mm va-lcp curved condylar plate/8 hole/195mm/right this is report 2 of 3 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data-h4.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/8 HOLE/195MM/RIGHT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10448770
• MDR Text Key: 204216478
• Report Number: 2939274-2020-03773
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042774
• UDI-Public: (01)10886982042774
• 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
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.408
• Device Catalogue Number: 02.124.408
• Device Lot Number: 51P2672
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Patient Sequence Number: 1
• Treatment: 2.5MM DRILL TIP GUIDE WIRE 200MM.; 4.3MM DRILL BIT/QC/180MM.; 4.5MM CRTX SCR SLF-TAPP 40MM.; 5.0MM VBLANG LCK SCR/SLF-TP30MM.; 5.0MM VBLANG LCK SCR/SLF-TP55MM.; 2.5MM DRILL TIP GUIDE WIRE 200MM.; 4.3MM DRILL BIT/QC/180MM.; 4.5MM CRTX SCR SLF-TAPP 40MM.; 5.0MM VBLANG LCK SCR/SLF-TP30MM.; 5.0MM VBLANG LCK SCR/SLF-TP55MM.