MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY

Model Number 04.037.155S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient identifier: additional patient identifier reported as: (b)(6). Device evaluated by mfr: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. (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 Description

It was reported that the patient underwent revision surgery of the total hip due to avascular necrosis (avn) of femoral head on (b)(6) 2019. The long proximal femoral nailing system (tfna) helical blade was in the patient's pelvis. The device was not broken. There was no surgical delay. Procedure was successfully completed. Patient was revised to a total hip replacement. This report is for one (1) tfna nail. This is report 2 of 3 for complaint (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 340MM/LEFT - 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: 8488178
• MDR Text Key: 141087485
• Report Number: 2939274-2019-57320
• Device Sequence Number: 1
• Product Code: HSB
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 04.037.155S
• Device Catalogue Number: 04.037.155S
• Device Lot Number: H180586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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: 04/05/2019 Patient Sequence Number: 1