MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX 2.8 TI W/NDL 22-0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202067
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that during a procedure the screw of the twinfix 2.8 pulled out.The procedure was completed using a back-up device and it is unknown if there was any surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).B5: updated.
Event or Problem Description
It was reported that during an ankle arthroscopy the screw of the twinfix 2.8 pulled out.The site was cleared from debris prior to insertion and it was prepared with surgical tools.The procedure was completed using a back-up device on the originally drilled hole, with a non-significant surgical delay.No further complications were reported patient is good.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an ankle arthroscopy, once the package of the screw of the twinfix 2.8 was opened, it was found the anchor fell off from the deployment device.The site was cleared from debris prior to insertion and it was prepared with surgical tools.The procedure was completed using a back-up device on the originally drilled hole, with a non-significant surgical delay.No further complications were reported patient is good.Results of investigation found the threads of the anchor are fractured and deformed.
Additional Manufacturer Narrative
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 insertion device, suture strings and anchor were returned with debris on them.The threads of the anchor are fractured and deformed.A functional evaluation could not be performed due to the damaged condition in which the device was received.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 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.A review of the material specifications found that no burrs, cracks, or contamination is allowed, and a certificate of conformance must also be provided.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force or torque, off-axis insertion, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX 2.8 TI W/NDL 22-0 ULTRABRAID
• 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: 16461414
• Report Number: 1219602-2023-00290
• Device Sequence Number: 2343507
• Product Code: MBI
• UDI-Device Identifier: 03596010619112
• UDI-Public: 03596010619112
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2022
• Device Model Number: 72202067
• Device Catalogue Number: 72202067
• Device Lot Number: 50695540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 03/09/2023; 11/29/2023; Not provided; 01/09/2024
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/15/2023; 12/07/2023; 01/08/2024; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown