MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/RT-STER; IMPLANT,FIXATION DEVICE,CONDYLAR PLATE

Model Number 02.124.416

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Additional product codes: hrs, hwc.The device was received, the investigation is in progess, 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 an unknown date during a procedure the locking hole of a 4.5mm va-lcp curved condylar plate/16 hole/336mm/right was stripped, which would not allow the aiming arm to be attached.There was a surgical delay of 5 minutes.The surgery was successfully completed.There is no known patient consequence.Patient¿s outcome is reported as stable.Concomitant devices reported: unk - guides/sleeves/aiming: aiming arm (part# unknown, lot# unknown, quantity# 1).This report is for 1 4.5mm va-lcp curved condylar plate/16 hole/336mm/right.This is report 1 of 1 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.Additional narrative: part number: 02.124.416s; synthes lot number: l822898; manufacturing site: mezzovico; release to warehouse date: 30.March 2018; expiry date: 01.March 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the 4.5mm va-lcp curved condylar plate/16 hole/336mm/right (p/n: 02.124.416, lot number: l822898) was received at us customer quality (cq).Upon visual inspection, the most proximal (bp-1) locking hole and the va-1 hole on the plate are stripped.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed: va-lcp curved condylar plate 6-22 holes / left and right curved condular plate.Complaint confirmed? yes, the locking hole threads are stripped.Hence confirming the allegation.The stripped condition of the hole might have contributed to the reported "unable to assemble" condition.Investigation conclusion: this complaint is confirmed for 4.5mm va-lcp curved condylar plate/16 hole/336mm/right (p/n: 02.124.416, lot number: l822898) as the locking hole is stripped.No definitive root cause could be determined based on the provided information.The potential cause could be due to unintended forces applied to the device.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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/16HOLE/336MM/RT-STER
• 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: 10063448
• MDR Text Key: 191248072
• Report Number: 2939274-2020-02358
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042934
• UDI-Public: (01)10886982042934
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.416
• Device Catalogue Number: 02.124.416S
• Device Lot Number: L822898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Date Manufacturer Received: 05/18/2020
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM