MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.413

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Part # 02.124.413.Lot number: 85p1799.Manufacturing site: (b)(4).Release to warehouse date: 19 jan 2021.Supplier: wrights lane synthes usa products llc.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2022 there was a removal of the variable angle (va) condyle plate and corresponding screws due to nonunion/malunion.The surgeon removed the plate and screws, realigned the femur, inserted im nail, and inserted bone graft obtained via radioimmunoassay (ria) procedure.There was no patient consequences.This report is for (1) 4.5 va-lcp crvd cond pl/12 hole/266/lft.This is report 1 of 12 for complaint (b)(4).

• Brand Name: 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14654053
• MDR Text Key: 294876907
• Report Number: 2939274-2022-02204
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042873
• UDI-Public: (01)10886982042873
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2022

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
• Device Operator: Health Professional
• Device Model Number: 02.124.413
• Device Catalogue Number: 02.124.413
• Device Lot Number: 85P1799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.5MM CORTEX SCREW SELF-TAPPING 32MM; 4.5MM CORTEX SCREW SELF-TAPPING 32MM; 4.5MM CORTEX SCREW SELF-TAPPING 32MM; 5.0 VA LCK SCRW/S/TAP /80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; CORTSCR Ø4.5 SELF-TAP L32 SST
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male