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

Catalog Number 72205135

Device Problems Fracture (1260); Failure to Fire (2610); Device Dislodged or Dislocated (2923)

Patient Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that during an arthroscopy procedure, when the shaft of the healicoil was pulled out after implant deployment, the distal anchor came off and the proximal anchor failed to deploy.The procedure was successfully completed without delay using a back-up device in an additional bone hole.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual inspection revealed the device was not returned with original packaging.The proximal body is missing, and anchor plug is broken almost in half.The distal tip is detached from device.No other physical damage is visible to the device.A functional evaluation of the returned device found that the mechanical portion of the device is in working order.Device passed functional test.Device functioned as per manufacture specifications.Based on the condition of the product material found during visual inspection, additional material testing is not required.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.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A review of the material specifications found that the tensile strength has been established.Also, material certificate of analysis (coa) is required for raw material.The root cause was associated with unintended use of the device.Factors that may have contributed to the reported event include not maintaining inserter alignment throughout insertion to ensure implant integrity or excessive force during insertion.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

Internal complaint reference: (b)(4).

• Brand Name: HEALICOIL KNOTLESS RGNST
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, 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: 12815121
• MDR Text Key: 280788729
• Report Number: 1219602-2021-02506
• Device Sequence Number: 1
• Product Code: MBI
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72205135
• Device Lot Number: 50950677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male