MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM/2.7MM VA-LOCKING NAVICULAR PLATE; PLATE,FIXATION,BONE

Model Number	02.211.220
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.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.(b)(4).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) 2019, the patient underwent removal of five (5) variable angle locking screws (removed from the distal end of plate), one (1) variable angle locking navicular plate, and six (6) cortex screws due to nonunion/malunion.A variable angle locking compression plate curved condylar plate was remained implanted because it was holding lateral length of the fracture.Originally, the patient had a distal femur fracture treated with va condylar plate and va navicular plate on an unknown date.The anatomy restored and fixed with zimmer medial plate.The variable angle distal femur plate reapplied with new five (5) screws.It was further reported that the five (5) cortex screws remained in the patient.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.This report is for one (1) 2.4mm/2.7mm va-locking navicular plate.This is report 2 of 5 for (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.Complainant part is not expected to be returned for manufacturer review/investigation.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: 2.4MM/2.7MM VA-LOCKING NAVICULAR PLATE
• 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: 8771222
• Report Number: 2939274-2019-59065
• Device Sequence Number: 2566567
• Product Code: HRS
• UDI-Device Identifier: 10886982054029
• UDI-Public: (01)10886982054029
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 02.211.220
• Device Catalogue Number: 02.211.220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR