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	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a rotator cuff repair surgery, it was noticed that after exiting the needle bar the q-fix suture broke.The suture was detached, and then the surgeon made a knot.It was not retrieved form the patient.The back up was used in an additional hole.The procedure was resumed, after a non-significant delay, using a competitor back up device.No further complications were reported.
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 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.
Additional Manufacturer Narrative
H11: h2: corrected information on: h6 (impact code).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an analysis of the customer provided image found a q-fix device lying on a fabric material, two ends of the suture can be seen next to the insertion device.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 that the suture diameter and knot pull suture strength are specified and a certificate of analysis is required with each shipment.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 (1) excessive force (2) misalignment of the implant and inserter handle (3) bending or twisting the insert handle during insertion.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).The reported device was received for evaluation.A visual inspection revealed the device was returned in original packaging with the batch number of the complaint on the label.The anchor and blue/white suture were not returned.The black/white suture was returned with a frayed break at its mid-point which is its approximate connection site to the anchor.The insertion device has no visible defect.Based on the condition of the product material found during visual inspection, additional material testing is not required.An analysis of the customer provided image found a q-fix device lying on a fabric material, two ends of the suture can be seen next to the insertion device.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 that the suture diameter and knot pull suture strength are specified and a certificate of analysis is required with each shipment.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 (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: 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: 24455916
• Report Number: 3006524618-2026-00094
• Device Sequence Number: 21176186
• Product Code: MBI
• UDI-Device Identifier: 00885556724644
• UDI-Public: 885556724644
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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: 2178623
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 04/15/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/04/2026; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2025
• 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