MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Model Number	02.124.418
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information is unknown.It is unknown when plate broke.Additional procodes: hrs, hwc.Lot number is unknown.Date of implantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Product was not returned and no lot number was provided.Based on the information available, 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.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent hardware removal of a variable angle (va) plate, eleven (11) va locking screws, four (4) cortex screws, and one (1) 6.5 or 7.3mm cannulated screw.It is not known when the variable angle (va) distal femur plate was implanted.The patient apparently stepped off a curb and the plate broke at the sixth most distal combi-hole due to non-union.Non-union of the mid-shaft and distal femur was confirmed by the surgeon after the entire implant system was removed.Surgeon reported to the sales consultant that it was a non-union rather than the plate's fault.The patient is scheduled for revision to a retrograde nail and distal femur plate on (b)(6) 2018.Explantation surgery was successful.It is unknown if there was a surgical delay.No patient outcome was reported.Concomitant devices: va locking screws (part: unknown, lot: unknown, quantity: 11); cortex screws (part: unknown, lot: unknown, quantity: 4); cannulated screw (part: unknown, lot: unknown, quantity: 1).This report is for a 4.5mm va-lcp curved condylar plate/18 hole/370mm/right.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT
• Common Device Name: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7710128
• Report Number: 2939274-2018-53016
• Device Sequence Number: 11424001
• Product Code: JDO
• UDI-Device Identifier: 10886982042972
• UDI-Public: (01)10886982042972
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.124.418
• Device Catalogue Number: 02.124.418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/23/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE DESCRIPTION, THERAPY DATE: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 91