MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12/130 DEG TI CANN TFNA 420/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.263S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A product investigation was conducted.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.Investigation summary = > 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.
Event or Problem Description
It was reported that on (b)(6) 2021, patient underwent a hardware removal procedure of a product trochanteric that broke inside the patient.Surgeon removed the broken implant before the total hip replacement.The date of the original surgery was on (b)(6) 2020.The products involved was a nail, that was broken and the live screw.Procedure was completed successfully without any surgical delay.Concomitant device reported: tfna fenestrated screw (part# 04.038.190; lot# 17p2186; quantity: 1) unknown tfna helical blade (part# unknown; lot# unknown; quantity: 1) this report is for one (1) 12mm/130 deg ti cann tfna 420mm/left-sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 12/130 DEG TI CANN TFNA 420/LEFT-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11740416
• Report Number: 2939274-2021-02136
• Device Sequence Number: 3832634
• Product Code: HSB
• UDI-Device Identifier: 10886982097439
• UDI-Public: (01)10886982097439
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• 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): 04/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.263S
• Device Catalogue Number: 04.037.263S
• Device Lot Number: HO58087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2021
• Initial Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR