MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 400MM/RIGHT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.260S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Product was not returned.Based on the information available, it has been determined that no corrective and/ or 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.(b)(4).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) 2020 the patient underwent a revision procedure for the addition of a plate due to a propagated fracture related to an implanted trochanteric fixation nail advanced (tfna) nail.Initially, on (b)(6) 2020 the patient was implanted with the reported devices for a distal 1/3 femur fracture as the patient had a total knee prosthesis (non-synthes) on 2017 distal to the original fracture.During the revision procedure a variable angle (va) condylar plate was implanted.The procedure was successfully completed with no surgical delay.Patient status was good.This report is for one (1) 12mm/ 130 deg ti cann tfna 400mm/ right-sterile.This is report 1 of 6 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 400MM/RIGHT-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10087941
• Report Number: 2939274-2020-02497
• Device Sequence Number: 2379661
• Product Code: HSB
• UDI-Device Identifier: 10886982097408
• UDI-Public: 10886982097408
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

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: 04.037.260S
• Device Catalogue Number: 04.037.260S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 74