MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number	72200755
Medical Device Problem Codes	Material Fragmentation (1261); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H6: the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The sutures are still on the device, run through the cannula, and tied at the cleat.The anchor has been fragmented, and two small pieces of it are inside the cannula of the insertion device.The rest of the anchor was not returned.Bio debris is present.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.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 anchor material specification found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.The root cause has been associated with unintended use of the device factors that could have contributed to the failure include excessive force used on the device.Based on this investigation, the need for corrective action is not indicated.
Event or Problem Description
It was reported that during a shoulder arthroscopy, when the first twinfix anchor was inserted, the meama progressed halfway through the tunnel, causing the anchor to be sprayed with the wrench.The anchor was removed from the patient.The procedure was completed without surgical delay using a back-up device.No further complications were reported.

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22023597
• Report Number: 1219602-2025-01125
• Device Sequence Number: 9164156
• Product Code: JDR
• UDI-Device Identifier: 03596010577986
• UDI-Public: 3596010577986
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 05/14/2025

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: 72200755
• Device Lot Number: 2153125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2024
• 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 Age: 46 YR
• Patient Sex: Unknown