MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL KNOTLESS RGNST; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72205135

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a arcr procedure, when the inserter of the healicoil was removed after the implantation of the anchor was completed, using the proper method, the proximal anchor came off the bone hole.The bone quality was soft.The procedure was successfully completed with a delay of 10 minutes using a competitor back up device (healix sp 6.5 - johnson & johnson).No further complications were reported.

Manufacturer Narrative

The reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.The distal anchor and distal plug were not returned.The proximal anchor was returned on the device with no visible defect.A functional evaluation was performed on the returned device and found the black (1) most proximal knob will rotate and move the distal anchor/plug rod as intended.The orange (2) larger knob will rotate and move the outer barrel/forks and proximal anchor as intended.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL KNOTLESS RGNST
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18383685
• MDR Text Key: 331219671
• Report Number: 1219602-2023-02506
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72205135
• Device Lot Number: 2116066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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