MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT; PLATE, FIXATION, BONE

Model Number	02.124.413
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa.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 history lot part: 02.124.413.Lot: l695264.Manufacturing site: (b)(4).Release to warehouse date: 15.December 2017.A manufacturing record evaluation was performed for the 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 or Problem Description
It was reported that on an unknown date, the patient underwent a removal of the variable angle (va) condylar plate for a distal femur replacement due to non-union of a periprosthetic distal femur fracture.During the removal procedure, the distal third of femur was resected and surgeon removed plate connected to the resected bone.It was also discovered during the case that one 4.5 cortex screw was broken.It is unknown if there was a patient consequence.Concomitant devices reported: unknown screw cortex (part# unknown, lot# unknown, quantity# 1), unknown screw-trauma (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 4.5mm va-lcp curved condylar plate/12 hole/266mm/left this is report 1 of 3 for (b)(4).(b)(4) will capture the post-op event where the patient underwent a removal procedure due to non-union of a periprosthetic distal femur fracture, (b)(4) will capture the intra-op event where the surgeon performed a resection to remove the the va-lcp plate.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9883741
• Report Number: 2939274-2020-01537
• Device Sequence Number: 2793964
• Product Code: HRS
• UDI-Device Identifier: 10886982042873
• UDI-Public: (01)10886982042873
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.124.413
• Device Catalogue Number: 02.124.413
• Device Lot Number: L695264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 03/28/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CORTEX; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 54