MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional classification code: hrs and hwc exact implant date is unknown.It occurred in (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).A review of the device history records has been requested.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 was treated for an orif (open reduction internal fixation) of a distal femur.On an unknown date, the plate was found to be broken, and it was discovered that the patient had developed a non-union, which reportedly led to the removing of the broken hardware.On (b)(6) 2017, the patient returned to the operating to remove broken plate, four (4) intact proximal screws and five (5) intact distal screws.The patient was revised to another plate and screw fixation with bone graft.There was no reported surgical delay, no fragments left in the patient, no additional medical or surgical intervention.The procedure was successfully complete, and the patient was stable during and following the surgery.Concomitant devices: unknown 4.5 cortex screw ss (part # unknown, lot # unknown, qty.1); unknown 5.0 variable angle locking screws ss (part # unknown, lot # unknown, qty.8).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 02.124.410, lot# l377249.Manufacturing location: (b)(4), release to warehouse date: apr 20, 2017.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.It is unknown if the device was reprocessed and reused on patient.Therapy date is unknown date in (b)(6) 2017.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.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is a single use device but was not reprocessed or reused.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/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: 7077160
• Report Number: 8030965-2017-50245
• Device Sequence Number: 16056650
• Product Code: JDP
• UDI-Device Identifier: 10886982042811
• UDI-Public: (01)10886982042811(10)L377249
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup,Followup
• Report Date (Section B): 11/01/2017

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: 02.124.410
• Device Catalogue Number: 02.124.410
• Device Lot Number: L377249
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/01/2017; 04/13/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 12/28/2017; 04/26/2018
• 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: 87 YR
• Patient Weight: 86