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

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)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event date for the patient missing a large amount of bone occurred in an unknown date in 2017.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 undergone a masquelet procedure on (b)(6) 2017 since the patient was missing a large amount of bone.The initial surgery was performed on (b)(6) 2017 by open reduction internal fixation procedure for treatment of a grade 3 open femur fracture.The hardware was implanted on (b)(6) 2017 during the initial surgery and included the following hardware (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.) all the implanted hardware was removed intact during revision surgery on (b)(6) 2018 due to infection and delayed healing, except for one 1-3.0 headless screw which not able to be removed and was left inside the patient.The procedure was successfully completed without any delay and the patient was ok after the surgery.This complaint, (b)(4), captured the event of the masquelet procedure.(b)(4), source complaint, captured the hardware removal due to infection and delayed healing.(b)(4) captured the screw that was not removed during revision surgery.This complaint involves seven (7) parts.This report is 1 of 7 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT
• 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: 7452071
• Report Number: 2939274-2018-51853
• Device Sequence Number: 173214
• Product Code: HRS
• 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: 04/23/2018
• 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