MAUDE Adverse Event Report: ARTHEX, INC. SUTURE ANCHOR COMPOSITE SWIVELOCK IMPLANT; FASTENER FIXATION BIODEGRADE, SOFT TISSUE

Model Number AR-2324BCC

Device Problem Break (1069)

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

Event Date 12/20/2019

Event Type  malfunction  

Event Description

During surgical procedure, repair talofibular ligament rupture of left foot, an arthrex suture anchor biocomposite broke.

• Brand Name: SUTURE ANCHOR COMPOSITE SWIVELOCK IMPLANT
• Type of Device: FASTENER FIXATION BIODEGRADE, SOFT TISSUE
• Manufacturer (Section D): ARTHEX, INC. ; 1370 creekside blvd. ; naples FL 34108 1945
• MDR Report Key: 9535736
• MDR Text Key: 173306611
• Report Number: MW5091944
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: AR-2324BCC
• Device Lot Number: 10387140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 80