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

Model Number	02.124.413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.X-ray review: the received x-ray shown that the implants are intact.Its seems that no allegation of a device malfunction.The complaint therefore has been determined to be unconfirmed.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 (b)(6) 2020, the patient underwent reamer/ irrigator/ aspirator (ria) bone harvest and a revision of devices due to a failed fixation distal femur fracture.The patient originally implanted with variable angle condylar plate 12 hole left and screws on an unknown date.The plate and screws were explanted.It was revised to zimmer retrograde femoral nail and also with a dual fixation with synthes va condylar plate 22 hole.The procedure was successfully completed.Patient status was stable.This complaint involves ten (10) devices.(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.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.
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.Part/lot combination are unknown at synthes gmbh, no dhr review possible.He received x-ray shown that the implants are intact.Its seems that no allegation of a device malfunction.The complaint therefore has been determined to be unconfirmed.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.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: 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: 9974836
• Report Number: 2939274-2020-01923
• Device Sequence Number: 11399609
• Product Code: JDP
• UDI-Device Identifier: 10886982042873
• UDI-Public: (01)10886982042873
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2020

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: 5L5181
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 05/11/2020; 05/13/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 05/11/2020; 05/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5MM VA-LCP CRVD CONYLR PLT/12 HLE/266MM/LFT; UNK - SCREWS: 5.0 MM CANNULATED; UNK - SCREWS: 5.0 MM CANNULATED; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR