MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 VA LCKNG SCR SLF-TPNG/SD/70; SCREW,FIXATION,BONE

Model Number	02.127.170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hrs 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.The 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 or Problem Description
It was reported that on (b)(6) 2021, the patient underwent for an opening wedge tibia osteotomy procedure to correct a valgus deformity associated with a previous mva.The patient had an unknown plate and screws on the posterior medial aspect of the proximal tibia.To perform the osteotomy procedure, the surgeon removed two 3.5mm locking screws from the posteromedial plate.The procedure outcome is unknown.No patient outcome.Concomitant device reported: unk - plate (part# unknown; lot# unknown; quantity: unknown).This complaint involves two (2) devices.This report is for (1) 3.5mm variable angle locking.This report is 2 of 2 for (b)(4).

• Brand Name: 3.5 VA LCKNG SCR SLF-TPNG/SD/70
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12228035
• Report Number: 2939274-2021-04282
• Device Sequence Number: 4062767
• Product Code: HWC
• UDI-Device Identifier: 10886982043368
• UDI-Public: (01)10886982043368
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 06/28/2021

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: 02.127.170
• Device Catalogue Number: 02.127.170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 VA LCKNG SCR SLF-TPNG/SD/70; UNK - PLATES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR