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

Catalog Number 25-2800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cyst(s) (1800)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, four years after a 2.8mm q-fix all suture anchor was implanted, the patient experienced reaction which caused the formation of a big cyst.A revision surgery of osteotome through the bone to reach the q-fix was made, and the cyst was drained out.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: part of the reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.Only the suture knot was returned with debris.Product was out of the original packaging.No packaging returned.A functional evaluation could not be conducted due to only portion of the suture being returned.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 concluded this was an isolated event.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.Based on the limited information provided the clinical root cause of the reported issue could not be determined and it cannot be concluded if this event 4 years later is a malfunction of the anchor.The device ifu does list ¿foreign body sensitivity to implant materials,¿ as a contraindication and we cannot rule out an undiagnosed foreign body sensitivity reaction to the implant materials as a contributing factor.Its not reported the type of symptoms this cyst was causing and why it necessitated draining unless just for diagnostic purposes which a final diagnosis was also not provided if known.The patient impact beyond the reported drainage cannot be determined.No further medical assessment is possible at this time based on the information provided.Should additional information become available, the medical assessment can be re-evaluated at that time.A review of the customer provided images it shows a cyst.There was no way to determine if the device contributed to the reported event.The complaint was confirmed but the root cause could not be determined as the condition in which the device was received did not allow for evaluation of the reported complaint.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.No containment or corrective actions are recommended at this time.

• 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: 12371149
• MDR Text Key: 268259883
• Report Number: 3006524618-2021-00872
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556724644
• UDI-Public: 885556724644
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: 25-2800
• Device Lot Number: 1173731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other