MAUDE Adverse Event Report: ARTHROCARE CORPORATION 1.8MM Q-FIX ALL SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	25-1800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/30/2026
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 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, after the insertion site was drilled using a 1.8 mm q-fix drill and guide, and cleared of all debris, a q-fix all suture anchor was deployed as usual using the twisting mechanism.The sutures were unwound from the cleat and were not snagged by the cleat while the anchor inserter was removed from the guide.The guide was removed and the suture strands did not appear to be attached to the anchor.The strands easily came out in their entirety.Upon inspection of the sutures, there was a distinct tear in the suture.The anchor body was left in the humerus.The procedure was resumed, after a 5 to 10 minutes delay, using a similar s+n back-up.The doctor elected to upsize the drill tunnel with a 2.8 mm q-fix drill and guide.A 2.8 mm q-fix was deployed into the tunnel without issues and repair of the subscapularis was performed without further issues.No further complications were reported.The patient is recovering well, with a normal expected postoperative recovery.The surgeon was satisfied with the surgical outcome.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: part of the reported device was received for evaluation.A visual inspection revealed that it was not returned in original packaging.The anchor and sutures were not returned.The distal insertion tube is bent and shows contact with a sharp device.Image attached.The cleat is fully extended.A functional evaluation was performed on the returned device and found that the spool cleat has been fully deployed 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 review of the material specifications found that the sutures must comply with a break strength of 8.4 - 10.4 lbs.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include an excessive force during use or suture contact with sharp objects.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: 1.8MM 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: 24413215
• Report Number: 3006524618-2026-00086
• Device Sequence Number: 5879603
• Product Code: MBI
• UDI-Device Identifier: 00885556724606
• UDI-Public: 885556724606
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 25-1800
• Device Lot Number: 2189553
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2025
• 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: Male
• Patient Weight: 112 KG