MAUDE Adverse Event Report: SMITH AND NEPHEW KNOTLESS SUTURE ANCHOR 5.5MM

Model Number 72290001

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  malfunction  

Event Description

When attempting to insert a knotless suture anchor, the tip of the anchor broke off.The md has experience and was using the normal amount of pressure during insert.There was no harm to the patient, and all pieces were removed.The procedure was completed by utilizing a different knotless suture anchor.

• Brand Name: KNOTLESS SUTURE ANCHOR 5.5MM
• Type of Device: SUTURE ANCHOR
• Manufacturer (Section D): SMITH AND NEPHEW; fort worth TX 76107
• MDR Report Key: 6510768
• MDR Text Key: 73558061
• Report Number: MW5069233
• Device Sequence Number: 1
• Product Code: MBI
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 72290001
• Device Lot Number: 1171775
• Was Device Available for Evaluation?: Yes
• 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: 59 YR
• Patient Weight: 70