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

Catalog Number 25-1800

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that during an unknown procedure, the q-fix suture anchor failed.The back of the anchor came out of the anchor.The procedure was completed using a s+n back up device in the originally drilled bone hole.There was no surgical delay.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

H10: h2: additional information: b1, b2, b4, h1.Corrected data: h6: health effect - clinical and impact code.

Event Description

It was reported that during an unknown procedure, the q-fix suture anchor failed, the back of the anchor broke, and all the broken pieces were removed.The procedure was completed using a s+n back up device in a new drilled bone hole.There was no surgical delay.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed that the device was not returned in any original packaging.The anchor, sutures, and cleat were not returned.The black driver block has descended to the bottom edge of the ratchet handle indicating it was fully deployed.A functional evaluation was performed on the returned device and found that the ratchet handle is fully turned and locked.An assessment of material characteristics 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 no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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 break strength requirements are specified.A clinical review states that based on the limited information provided the clinical root cause of the reported event cannot be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.No further risk to the patient is anticipated as a result of the additional bone hole.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 excessive force, or suture contact with sharp objects.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

H11: corrected information in h6 (health effect - impact code).

• Brand Name: 1.8MM Q-FIX ALL SUTURE ANCHOR
• Type of Device: 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18858425
• MDR Text Key: 337200120
• Report Number: 3006524618-2024-00091
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556724606
• UDI-Public: 885556724606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25-1800
• Device Lot Number: 2131273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other