MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72200755

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during a shoulder cuff repair surgery, after implanted the twinfix suture anchor pulled out.The procedure was successfully completed using a back-up device in the original drilled bone hole, and a 4.5 starter was used to clear the insertion site.With no delay.No further complications were reported.Preliminary results of investigation found the anchor is fractured at the suture window and has biological debris on it.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The anchor was returned without the insertion device or suture material.The anchor is fractured at the suture window and has biological debris on it.A review of the customer provided image finds the anchor from the complaint device, fractured at the suture window.Based on the condition of the product material found during visual inspection, additional material testing is not required.A functional evaluation could not be performed due to the broken anchor.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 anchor specifications found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.The root cause was associated with unintended use of the device.Factors that could have contributed to the break 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.Factors that could have contributed to the pull out include inadequate bone quality, improper preparation of the insertion site, or off-axis insertion of the device.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The anchor was returned without the insertion device or suture material.The anchor is fractured at the suture window and has biological debris on it.A review of the customer provided image finds the anchor from the complaint device, fractured at the suture window.Based on the condition of the product material found during visual inspection, additional material testing is not required.A functional evaluation could not be performed due to the broken anchor.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 anchor specifications found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.The root cause was associated with unintended use of the device.Factors that could have contributed to the break 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.Factors that could have contributed to the pull out include inadequate bone quality, improper preparation of the insertion site, or off-axis insertion of the device.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• 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: 15746869
• MDR Text Key: 303214298
• Report Number: 1219602-2022-01690
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010577986
• UDI-Public: 03596010577986
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2023

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 Model Number: 72200755
• Device Catalogue Number: 72200755
• Device Lot Number: 2065597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 09/26/2023; 09/26/2023
• Supplement Dates FDA Received: 10/02/2023; 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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
• Patient Outcome(s): Other