MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA HA 4.5 W/2 UB (WH & BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72202597
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 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 risks with the device itself or with its use 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 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.
Event or Problem Description
It was reported that during a rotator-cuff repair surgery, one (1) twinfix ultra anchor split.All the pieces were removed from patient with tweezers and suction.The procedure was resumed without delay using an equivalent sn backup on the originally drilled bone hole of 4.5mm, no void was left in patient.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: case-(b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent 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.A review of the 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.An analysis of the customer provided image found one device lying on its packaging, the anchor is in place with a split near the tip.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include an inadvertent impact event that may have occurred during device transportation, rough shipping and handling, or at the customer site, as well as the application of an unintended, inappropriate, or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual evaluation showed the devices were returned in a single original packaging with the batch number of the complaint on the label.The sutures were not returned.The anchor has been fragmented.The rest of the anchor was not returned.The insertion device has no visible defect.Bio debris is present.A second anchor with sutures was returned with no lot number or identification.The second anchor with sutures has no visible defect.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 the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.An analysis of the customer provided image found one device lying on its packaging, the anchor is in place with a split near the tip.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include an inadvertent impact event that may have occurred during device transportation, rough shipping and handling, or at the customer site, as well as the application of an unintended, inappropriate, or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TWINFIX ULTRA HA 4.5 W/2 UB (WH & BLUE
• 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: 23804793
• Report Number: 1219602-2025-03211
• Device Sequence Number: 12661565
• Product Code: MAI
• UDI-Device Identifier: 03596010647559
• UDI-Public: 3596010647559
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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: 72202597
• Device Lot Number: 2144328
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/19/2026; 03/26/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/20/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2024
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 59 KG