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

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Reporter is synthes sales consultant. A review of the device history records has been requested. 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 a patient underwent a revision surgery on (b)(6) 2018 as it was found out that a trochanteric femoral nailing advanced (tfna) nail broke at the junction of the helical blade a few months after a patient had a hip fracture fixed with tfna. The nail was removed, and a total hip arthroplasty was done. There were no fragments generated from the broken device and it was removed without incident. Surgical delay and procedure outcome is unknown. Patient status is unknown. Concomitant devices reported: tfna fenestrated helical blade 100mm (part# 04. 038. 400, lot# h557037, quantity 1); screw (part # unknown, lot # unknown, quantity 1). This report is for one (1) tfna nail. This is report 1 of 1 for complaint (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 400MM/RIGHT-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8130389
• MDR Text Key: 129295010
• Report Number: 2939274-2018-55270
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097408
• UDI-Public: (01)10886982097408
• 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

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.037.260S
• Device Catalogue Number: 04.037.260S
• Device Lot Number: H562967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• 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: 12/04/2018 Patient Sequence Number: 1