MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TF ULTRA 2 UBRAID AND NDLS 5.5MM TI; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202618
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a shoulder surgery, when passing the twinfix ultra suture anchor through the bone, the screwdriver rolled over the head of the anchor, preventing its full entry.The procedure was completed with a surgical delay greater than 30 minutes, and it is unknown how the procedure was completed.The patient's health condition is stable.No further complications were reported.
Event or Problem Description
It was reported that during a shoulder surgery , when passing the twinfix ultra suture anchor through the bone, the screwdriver rolled over the head of this, preventing its full entry.The procedure was completed with a competitor device in an additional bone hole, resulting in a surgical delay of more than 30 minutes.A void was left in the patient.The patient's health condition is stable.No further complications were reported.
Additional Manufacturer Narrative
H2: additional information in b5.H11: corrected information in h6 (health effect - clinical and impact code).
Additional Manufacturer Narrative
H11: h2: additional information in d4 and h4.H3, h6: the reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The sutures have been cut off and are visible in the eyelet of the anchor.The cut sutures and needles were not returned.The metal anchor has been in contact with another instrument.It has deformed the threads on the proximal end.The insertion device has no visible defect.Bio debris is present.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 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 factors, that can contribute to the complaint event, include an application of unintended inappropriate or excessive force to the 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: TF ULTRA 2 UBRAID AND NDLS 5.5MM TI
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21533518
• Report Number: 1219602-2025-00500
• Device Sequence Number: 7857492
• Product Code: MBI
• UDI-Device Identifier: 03596010656131
• UDI-Public: 3596010656131
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K100159
• 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
• Report Date (Section B): 06/18/2025

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: 72202618
• Device Lot Number: 2151409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/18/2025; 06/17/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/24/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2024
• 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 Sex: Male