MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/2 UB-WHT & BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202599

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2020

Event Type  Injury  

Event Description

It was reported that during a repair of medial collateral ligament of knee joint, the anchor was fractured.Backup device was available to complete the procedure.It is unknown if a delay happened.However, no patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h3,h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer, found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A visual inspection of the returned device found that it is not in its original packaging.The device has been deployed, and the distal end of the anchor is fractured.There is debris on the anchor, sutures, and shaft of the device.Based on the condition of the product material found during visual inspection, additional material testing is not required.A review of the customer provided images found that the device has been deployed, and the anchor is in a pouch with the handheld device.The anchor is fractured.Although the tip of the anchor reportedly snapped, off in the patient during the rotator cuff procedure.Per communications, the tip was successfully removed.Based on the information provided, the procedure completed with a competitor¿s device.Since there was no delay or patient complications reported; no further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

Event Description

It was reported that during a repair of medial collateral ligament of knee joint, the twinfix anchor was fractured.Pieces were successfully removed from the patient.Backup device was available to complete the procedure.Non-significant delay and no further complications were reported.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/2 UB-WHT & BL
• 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: 10751964
• MDR Text Key: 213638490
• Report Number: 1219602-2020-01683
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647474
• UDI-Public: 03596010647474
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2024
• Device Model Number: 72202599
• Device Catalogue Number: 72202599
• Device Lot Number: 2033256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• 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 Age: 17 YR
• Patient Sex: Female
• Patient Weight: 60 KG