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

Model Number	72290002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7358770
• Report Number: 3006524618-2018-00142
• Device Sequence Number: 10940035
• Product Code: MBI
• UDI-Device Identifier: 00885556614211
• UDI-Public: (01)00885556614211(17)190629(10)1155660
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1