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

Catalog Number 72290002

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/18/2018

Event Type  malfunction  

Event Description

It was reported that a second anchor was attempted to be put into the bone however due to no visualization the second anchor was hit into the first anchor therefore snapping the anchor.No backup was available.No patient injuries were reported.

Manufacturer Narrative

The device was not returned for evaluation.A relationship between the device and reported incident cannot be established as the product was not returned.From information provided, reported that a second anchor was attempted to be put into the bone however due to no visualization the second anchor was hit into the first anchor therefore snapping the anchor.A customer complaint cannot be verified due to the product was not returned for evaluation.Root cause is unable to determined; however based on the customer information the most possible cause for the failure may be due to no visualization.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• 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 west william cannon drive; austin, TX 78735
• MDR Report Key: 7492169
• MDR Text Key: 107600873
• Report Number: 3006524618-2018-00225
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K153669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72290002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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