MAUDE Adverse Event Report: ARTHROCARE CORPORATION QFIX 1.8 MINI SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72290123
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an open arfl reconstruction procedure, the suture of the 1.8 q fix anchor broke while the suture was being ligated.The procedure was resumed, using an equivalent s+n backup.It is unknown whether any delay occurred.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H11: h3, h6: part of the device, used in treatment, was received for evaluation.A visual evaluation showed the device was not returned in original packaging.The anchor and sutures were not returned.The tube ferrule has been pushed back into the handle body allowing the insertion tube to move around freely.Bio debris is inside the tube.The cleat is fully extended.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 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 found that suture strength requirements are specified.A certificate of analysis is required with each shipment verifying suture diameter & knot pull suture strength.The root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that can contribute to the reported event include excessive force or contact with a sharp grasper/instrument.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: h2: corrected data on h6 (type of investigation & investigation findings) and on h11: results of investigation.H3, h6: part of the device, used in treatment, was received for evaluation.A visual evaluation showed the device was not returned in original packaging.The anchor and sutures were not returned.The tube ferrule has been pushed back into the handle body allowing the insertion tube to move around freely.Bio debris is inside the tube.The cleat is fully extended.A material assessment could not be performed due to the part not being returned for evaluation.However, an image evaluation was performed and found a broken suture near to the q fix device.The suture shows frayed threads.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 specification found that suture strength requirements are specified.A certificate of analysis is required with each shipment verifying suture diameter & knot pull suture strength.The root cause 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 excessive force or contact with a sharp grasper/instrument.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: QFIX 1.8 MINI 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: 23392435
• Report Number: 3006524618-2025-00614
• Device Sequence Number: 21293054
• Product Code: MBI
• UDI-Device Identifier: 00885556662618
• UDI-Public: 885556662618
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172165
• 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): 01/30/2026

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: 72290123
• Device Lot Number: 2181651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 12/02/2025; 01/28/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/03/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2025
• 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