MAUDE Adverse Event Report: ARTHREX SWIVELOCK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE

Model Number AR-2324BCC

Device Problem Unraveled Material (1664)

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

Event Date 09/26/2018

Event Type  Injury  

Event Description

Suture anchor "unraveled" upon initial insertion.Anchor was removed from the field and a new anchor of the same type and size was opened and used on the pt.

• Brand Name: SWIVELOCK SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE
• Manufacturer (Section D): ARTHREX; naples FL
• MDR Report Key: 7979088
• MDR Text Key: 124385080
• Report Number: MW5080653
• Device Sequence Number: 1
• Product Code: MBI
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: AR-2324BCC
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: 10216241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 101