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

Model Number	02.124.416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event date for delayed healing and infection is unknown.Additional product codes: hrs, hwc.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient had to undergo a revision surgery on (b)(6) 2018 for removal of hardware due to infection and delayed healing.The hardware was implanted (one 4.5mm va-lcp curved condylar plate/16 hole/336mm/right, four 5.0mm cannulated locking screws, one 5mm locking screws, four 4.5mm cortex screws, two 3.5mm cortex screws, 3.0mm headless screw and 1-3.0mm headless screw) on (b)(6) 2017 by open reduction internal fixation procedure for treatment of a grade 3 open femur fracture.After the implantation of hardware on (b)(6) 2017, the patient underwent a masquelet procedure on (b)(6) 2017 as the patient was missing a large amount of bone, which is captured under (b)(4).After all these the patient suffered from infection and delayed healing so the hardware was removed during a revision surgery on (b)(6) 2018.All the implanted hardware was removed intact, except for one 1-3.0 headless screw which not able to be removed and was left inside the patient and was captured in (b)(4).After the removal of hardware both stimulant beads and antibiotic spacer were placed.The surgery was successfully completed without any delay and the patient was ok after the surgery.This complaint involves seven (7) parts.This is report 1 of 7 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT
• 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: 7446740
• Report Number: 2939274-2018-51771
• Device Sequence Number: 19261400
• Product Code: JDP
• UDI-Device Identifier: 10886982042934
• UDI-Public: (01)10886982042934
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.124.416
• Device Catalogue Number: 02.124.416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 86