MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72202602
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, the twinfix ultra anchor fractured when tried to be implanted.Surgery was completed with a back-up device in the originally drilled bone hole, instead.There was a delay of less than 30 minutes, and no further complications were reported.Patient's status is good.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H10: internal complaint reference:(b)(4).B5 and h6 updated.
Event or Problem Description
It was reported that, during surgery, the twinfix ultra anchor fractured when tried to be implanted.Broken pieces were successfully removed from the patient with tweezers.Surgery was completed with a back-up device in the originally drilled bone hole, instead.There was a delay of less than 30 minutes, and no further complications were reported.Patient's status is good.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned with any original packaging.The anchor was not returned.The sutures are run through the cannula and tied at the cleat.The insertion device has no visible defects.A functional evaluation of the device could not be performed due to the anchor has already been deployed.An image evaluation revealed a broken anchor beneath a plastic wrap.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 no 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 raw material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Other factor lines include hat could have contributed to the reported event include excessive force on the device, adverse impact events, or attempted reuse of a single use device.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.

• Brand Name: TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21749220
• Report Number: 1219602-2025-00732
• Device Sequence Number: 17142191
• Product Code: MAI
• UDI-Device Identifier: 03596010647573
• UDI-Public: 3596010647573
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151105
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2025

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: 72202602
• Device Lot Number: 2109629
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 05/06/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/08/2025; 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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