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

Catalog Number	72290123
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/24/2025
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 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 an arthroscopy, the qfix 1.8 mini suture was cut or detached from the anchor when removing the anchor and guide after deployment.The anchor was left in the patient¿s bone but without suture to work with.Surgery was completed using a back-up device instead, placed in an additional drilled bone hole.A small void, a 1.8 drilled hole, was left in the patient.There was a surgical delay of less than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference case- (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not 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.Factors that could have contributed to the adverse event was likely caused partially or wholly by the user of the product as the mini suture was cut/detached from the anchor when removing the anchor and guide after deployment of the anchor.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for further assessment.
Additional Manufacturer Narrative
H10, h3, h6: part of the device, used in treatment, was received for evaluation.A visual inspection revealed 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 and on the anchor.The cleat is fully extended.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 investigation.Factors that can contribute to the reported event include (1) excessive force (2) improper alignment of the handle.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: 22802224
• Report Number: 3006524618-2025-00432
• Device Sequence Number: 7656649
• Product Code: MBI
• UDI-Device Identifier: 00885556662618
• UDI-Public: 885556662618
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2025

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: 72290123
• Device Lot Number: 2173355
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 12/26/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/01/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2025
• 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