MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 VA-LCP CURVED COND PL/8 HOLE/195/RT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Malunion of Bone (4529)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional product code : hrs hwc.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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Investigation summary the implant(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed, and the complaint condition could not be confirmed, there are no issues with the device.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot number is unknown therefore no mre can be performed.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 on (b)(6) 2021, the patient underwent hardware removal followed by osteotomy correction with nail due to malunion.Initially, the patient was implanted with variable angle (va) condylar plate.It was unknown if the surgery completed successfully.The patient outcome unknown.This complaint involves twelve (12) devices.This report is for (1) 4.5 va-lcp curved cond pl/8 hole/195/rt.This report is 1 of 10 (b)(4).(b)(4) captures the 10 of 12 devices was linked to (b)(4) that captures the remaining 2 of 12 devices.

• Brand Name: 4.5 VA-LCP CURVED COND PL/8 HOLE/195/RT
• 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: 11651529
• Report Number: 2939274-2021-01800
• Device Sequence Number: 11683164
• Product Code: JDP
• UDI-Device Identifier: 10886982042774
• UDI-Public: (01)10886982042774
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 02.124.408
• Device Catalogue Number: 02.124.408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: LOCKING: VARIABLE ANGLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR