MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE; BIO SOFT TISSUE FIXATN FASTNR

Model Number 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  malfunction  

Event Description

On 2/2/2024, it was reported by a sales representative via email that (2) ar-2324kbcct swivelock anchors were pulled out of the bone when attempting to tension the knotless mechanism in a medial row for a double pulley ripstop with rotator cuff repair.The anchors were removed and no pieces broke inside the patient.The case was completed with no further information provided.This was discovered during a rotator cuff repair procedure on (b)(6) 2024, with no reported patient harm.

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.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Type of Device: BIO SOFT TISSUE FIXATN FASTNR
• 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: jared engle ; 8009337001
• MDR Report Key: 18758561
• MDR Text Key: 336002659
• Report Number: 1220246-2024-01063
• Device Sequence Number: 1
• Product Code: MAI
• 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: 02/22/2024

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 Expiration Date: 04/30/2024
• Device Model Number: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Device Catalogue Number: AR-2324KBCCT
• Device Lot Number: 11012776
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2020
• 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