MAUDE Adverse Event Report: ARTHROCARE CORP. 2.8MM Q-FIX ALL SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 25-2800

Device Problem Break (1069)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during an arthroscopy, when the surgeon tied the arthroscopic sliding knot, he reduced the knot down onto the tissue and when the knot was approaching the tissue, the suture just snapped at the knot.The procedure was completed with a s+n back up device.The back up device was used in an additional bone hole.No void was left in the patient.Current status of the patient is fine.There was a significant delay and no further complications were reported.

Manufacturer Narrative

H6 health effect - impact codes were updated.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the material specification form found a certificate of analysis is required with each shipment.The suture diameter and knot pull strength is verified.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.Our clinical investigation concluded: this case reports the breakage of the suture during the implantation of the q-fix anchor.No clinically relevant supporting documentation was provided for inclusion in a medical investigation.Based on the limited information provided the root cause of the reported issue cannot be determined.The q-fix anchor is implantable, biocompatibility is not an issue.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.Per case details an additional bone hole was required to complete the procedure and the impact to the patient is expected to be minimal.No further clinical/medical assessment is warranted at this time.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.H6, health effect - clinical code was corrected.

Event Description

It was reported that, during an arthroscopy, when the surgeon tied the arthroscopic sliding knot of the q-fix anchor, he reduced the knot down onto the tissue and when the knot was approaching the tissue, the suture just snapped at the knot.The procedure was completed with a s+n back up device.The back up device was used in an additional bone hole.No void was left in the patient.Current status of the patient is fine.There was a significant delay and no further complications were reported.

• Brand Name: 2.8MM Q-FIX ALL SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14675851
• MDR Text Key: 293912438
• Report Number: 3006524618-2022-00287
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556724644
• UDI-Public: 885556724644
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25-2800
• Device Lot Number: 2080125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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): Other; Required Intervention