MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.414
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of event: unknown date in 2017.Additional product codes: hrs, hwc.Implant date: unknown date in (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.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 patient had an open reduction internal fixation revision on (b)(6) 2017 for a broken plate and nonunion.It is unknown the exact date of implantation but it is thought that it was sometime in (b)(6) 2017.Procedure was completed successfully with a positive patient outcome.Concomitant device(s) reported: screws (part/lot unknown, quantity unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/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: 7164067
• Report Number: 2939274-2018-50070
• Device Sequence Number: 16597520
• Product Code: JDP
• UDI-Device Identifier: 10886982042897
• UDI-Public: (01)10886982042897(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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: 02.124.414
• Device Catalogue Number: 02.124.414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/04/2018
• 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: 61 YR
• Patient Weight: 154