MAUDE Adverse Event Report: ARTHROCARE CORPORATION 2.8MM Q-FIX ALL SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	25-2800
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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, the suture of a 2.8mm q-fix all suture anchor didn¿t deploy from the anchor.The insertion site was cleared of all debris prior to insertion.Then it was not possible to use the same hole because while pulling the q-fix anchor out it creates a bigger hole.So, they took a healicoil anchor instead.The procedure was resumed, after a non-significant delay, using a similar s+n back-up product.The current status of the patient is good.No further complications were reported.
Additional Manufacturer Narrative
H10 h3, h6: part of the device, used in treatment, was received for evaluation.A visual inspection showed the device was not returned in original packaging.The anchor was not returned.Bio debris is inside the tube.The sutures have been cut from the anchor and are wrapped around the cleat.The cleat is fully extended.A functional evaluation showed the spool cleat is fully extended from the body of the handle and the ratchet is locked.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 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 (1) incorrect bone hole preparation (2) improper depth insertion and (3) excessive force.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: 2.8MM Q-FIX ALL SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23729870
• Report Number: 3006524618-2025-00690
• Device Sequence Number: 18577709
• Product Code: MBI
• UDI-Device Identifier: 00885556724644
• UDI-Public: 885556724644
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133727
• 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
• Report Date (Section B): 01/20/2026

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: 25-2800
• Device Lot Number: 2182729
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2025
• 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 Sex: Unknown