MAUDE Adverse Event Report: ARTHROCARE CORP. MULTIFIX S-ULT 6.5MM KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72290002

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2018

Event Type  malfunction  

Event Description

It was reported that the screw was still attached after it disengaged from the implant.A competitors implant (interference screw) was inserted over the eyelet of the s&n device to lock up the tension and secure the repair.No patient injury or other complications were reported.

Manufacturer Narrative

The reported multifix s- ultra device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.An exact root cause cannot be determined without evaluating the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force applied.Or (2) levering the device during insertion.Excessive force or levering the product during or after insertion can result in damage to the product.

• Brand Name: MULTIFIX S-ULT 6.5MM KNOTLESS ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon dr.; austin, TX 78735
• MDR Report Key: 7358770
• MDR Text Key: 103414096
• Report Number: 3006524618-2018-00142
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556614211
• UDI-Public: (01)00885556614211(17)190629(10)1155660
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132590
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2019
• Device Model Number: 72290002
• Device Catalogue Number: 72290002
• Device Lot Number: 1155660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1