MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	7210707
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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.
Event or Problem Description
It was reported that during a shoulder arthroscopy, two(2) twinfix 3.5 suture anchors fractured in half when they were inserted in the bone.With the second anchor they used a 1.7 drill bit to prevent the fracture, but it still occurred.The sutures of the anchors came out of the patient.The anchors were left in the patient's bone.The procedure could not be completed, and no other surgery was programmed.It is unknown if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H2: corrected data and additional information: d4 and h4.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H2: corrected data: b5.
Event or Problem Description
It was reported that during a shoulder arthroscopy, the twinfix 3.5 suture anchors fractured in half when they were inserted in the bone.The sutures of the anchor came out of the patient.The anchor was left in the patient's bone.The procedure could not be completed, and no other surgery was programmed.It is unknown if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H2: additional information: h6: medical device problem code.H3, h6: the reported device was received for evaluation.A visual inspection revealed a returned device in original packaging with the batch number 2177454 on the label.The device is missing half of its handle.The needles suture, and anchor were not returned.The distal end of the shaft is bent.Bio debris is present.A material assessment could not be performed due to the part not being returned for 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 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 material specification and work instructions found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.Before loading the device into pouch, it must be inspected for integrity and particulate.The root cause of the bent shaft and damaged handle could not be determined since findings cannot lead to a clear cause of the reported event.Factors that can contribute to the failures include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22935068
• Report Number: 1219602-2025-02169
• Device Sequence Number: 13241587
• Product Code: MBI
• UDI-Device Identifier: 03596010532190
• UDI-Public: 3596010532190
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K972326
• 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,Followup,Followup,Followup
• Report Date (Section B): 03/09/2026

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: 7210707
• Device Lot Number: 2177454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2025
• Supplement Date Received by Manufacturer: Not provided; 01/05/2026; 03/06/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/02/2025; 02/03/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2025
• 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: 26 YR
• Patient Sex: Male