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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: case-(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 alter 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, after opening the hole with the 4.5 tap, the twinfix anchor broke when screwed in.The broken pieces were removed from the patient.The procedure was completed with a surgical delay of less than 30 minutes using an equivalent s&n back-up device in the original bone hole.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.However, an image evaluation was performed and found on image one the tip of the anchor broken while being on the insertion device.Image two shows an arthroscopic view of the screw during insertion.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.A clinical review states per case details the broken pieces were retrieved from the patient.A photo of the device and an intraoperative photo were provided for review, the photos confirm the reported; however, they do not indicate a root cause for the reported event.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time 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 failure include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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: 24742297
• Report Number: 1219602-2026-00949
• Device Sequence Number: 13036759
• 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
• Report Date (Section B): 05/14/2026

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: 2144329
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2024
• 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 Sex: Unknown