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

Catalog Number	72202895
Medical Device Problem Codes	Premature Activation (1484); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).
Event or Problem Description
It was reported that during a rotator cuff repair, when inserted and removed that shaft, only the tip of the twin fix ultra anchor remained inserted, anchor was removed as per this malfunction.It is unknown if there was a smith and nephew back up device and how the procedure was completed.There was a delay of 8 minutes and no further complications were reported.
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications 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.Factors that can contribute to the reported event include excessive force on the device, excessive torque on the device, off-axis insertion, or improper preparation of the insertion site.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during a rotator cuff repair, when inserted and removed that shaft, only the tip of the twin fix ultra anchor remained inserted, which is released before removing the screw.The anchor was removed with kelly clamps.It is unknown if there was a smith and nephew back up device available.There was a delay of 8 minutes and no further complications were reported.

• Brand Name: TWINFIX ULTRA 5.5MM W/2 UB (WHT & BLUE)
• Common Device Name: 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: 18966046
• Report Number: 1219602-2024-00588
• Device Sequence Number: 15224989
• Product Code: MBI
• UDI-Device Identifier: 03596010652263
• UDI-Public: 03596010652263
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K152566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72202895
• Device Lot Number: 2123881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 05/09/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 05/10/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown