MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number 4.75MM BC KNOTLESS SWIVELOCK

Device Problems Break (1069); Entrapment of Device (1212); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a procedure, after the surgeon implanted the swivelock into the lateral row, the orange tab and retention sutures were released.Following the removal of the swivelock driver, the retention sutures pulled out with the driver.A piece of the peek eyelet broke off where the knotless mechanism runs underneath it.Recessed eyelet piece and sutures were lodged into the driver causing the surgeon to be unable to use the new knotless mechanism.No further information provide.Further information requested.Additional information provided 6/11/21: the entire implant is left in the patient.The anchor body was fine and the surgery was completed.The retention sutures ripped through the bottom and came out with the driver, thus being unable to use the knotless mechanism.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12076168
• MDR Text Key: 261492399
• Report Number: 1220246-2021-03334
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10888867351285
• UDI-Public: 10888867351285
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4.75MM BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KBCC
• Device Lot Number: 12174936
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/28/2021
• Date Device Manufactured: 11/25/2020
• 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