MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 90MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.038.190

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional device product code: ktt. (b)(4). The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 october 22, 2020, the patient underwent removal of a proximal femoral nailing system (tfna) due to tfna fenestrated screw broke in the thread. During the procedure the tfna nail, fenestrated screw and a distal locking screw were removed successfully without further damage and the patient was revised to a bipolar hip. The femur split during implantation of bipolar hip and a cerclage cable was used to stabilize the femur and implant. The procedure was successfully completed. The patient's status is unknown. Concomitant device reported: tfna nail (part #: 04. 037. 242, lot #: h607959, quantity: 1), unknown locking screw (part #: unknown, lot #: unknown, quantity: 1). This report is for one (1) tfna fenestrated screw 90mm. This is report 1 of 1 for complaint (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 90MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10869471
• MDR Text Key: 217161609
• Report Number: 2939274-2020-05235
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098726
• UDI-Public: (01)10886982098726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.038.190
• Device Catalogue Number: 04.038.190
• Device Lot Number: 17P3920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2019
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/19/2020 Patient Sequence Number: 1

Treatment

12MM/130 DEG TI CANN TFNA 170MM - STERILE; UNK - SCREWS: LOCKING