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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Malunion of Bone (4529)

Event Type  Injury  

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 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
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11651529
• MDR Text Key: 244977202
• Report Number: 2939274-2021-01800
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042774
• UDI-Public: (01)10886982042774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.124.408
• Device Catalogue Number: 02.124.408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR