MAUDE Adverse Event Report: ARTHREX, INC. SCORPION SUREFIRE NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number AR-13991N

Device Problems Component Missing (2306); Failure to Advance (2524); Device Or Device Fragments Location Unknown (2590)

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

Event Date 04/11/2016

Event Type  malfunction  

Event Description

Surgeon was going to pass the suture for the second anchor.Suture was unable to be passed.When instrument was withdrawn, it was discovered that the tip was gone above the notch.Surgeon used shaver suction around and below the cuff.Unsure if tip was removed.Manufacturer response for suture passer, scorpion sure fire needle (per site reporter): sales representative was present at procedure.

• Brand Name: SCORPION SUREFIRE NEEDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 168 brea canyon rd; walnut, CA 91789
• MDR Report Key: 5614276
• MDR Text Key: 43880807
• Report Number: 5614276
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: AR-13991N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR