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	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of postoperative plate breakage is unknown.Additional device product codes: jdp, hwc.Implanted in (b)(6) 2017; exact date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation, as part was discarded by the facility.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 an open reduction internal fixation of the distal femur using a variable angle plate in (b)(6) 2017.The patient went on to develop a non-union and a bone graft was performed in (b)(6) 2017.The patient presented to the hospital emergency room with a failed union and a broken plate on an unknown date.The patient was revised on (b)(6) 2018, when the broken plate was easily removed and the patient was implanted with a retrograde stryker nail.The surgery was successfully completed without any intraoperative events or harm to the patient.There were no surgical delays reported.The explanted plate was discarded and will not be returned for investigation.Concomitant devices reported unknown screws (part # unknown, lot # unknown, quantity unknown).This report is for the (b)(6) 2018, revision when the broken plate was removed and the patient was implanted with a retrograde stryker plate, (b)(4) is for the bone graft performed in (b)(6) 2017 due to a non-union.This is report 1 of 1 for complaint (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: 7421642
• Report Number: 2939274-2018-51585
• Device Sequence Number: 13591960
• Product Code: HRS
• UDI-Device Identifier: 10886982042934
• UDI-Public: (01)10886982042934(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2018

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: 02.124.416
• Device Catalogue Number: 02.124.416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/11/2018
• 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: 42 YR
• Patient Weight: 68