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

Catalog Number 25-1800

Device Problem Unintended Ejection (1234)

Patient Problem No Information (3190)

Event Date 09/02/2020

Event Type  Injury  

Event Description

It was reported that during an unknown procedure, the shaft did not retract even if the dial was turned all the way, and the anchor was deployed inside the shaft.For the first q-fix all-suture anchor, an additional bone hole was performed.Backup device was available to complete the procedure.No delay and no patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an repeated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that excessive force can result in anchor deployment failure.Clinical evaluation was completed and concluded that per complaint details, currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided the non-deployment of two q-fix anchors in addition to, the two additional bone holes required did not result in harm to the patient.However, it is unknown if a third bone hole was required.Per report, a backup device completed the procedure.Since there was no report of a delay or harm to the patient; no further clinical medical assessment is warranted at this time.Should additional medical information be provided, this complaint will be re-assessed.Visual evaluation shows the implant deployed inside the shaft which is slightly bent.The device was dismantled and no manufacturing discrepancies were observed inside the instrument.The device is intended for single use and functional test is not possible.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: 1.8MM 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
• MDR Report Key: 10670907
• MDR Text Key: 211048555
• Report Number: 3006524618-2020-00874
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556724606
• UDI-Public: 885556724606
• Combination Product (y/n): N
• PMA/PMN Number: K133727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

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 Expiration Date: 09/01/2023
• Device Catalogue Number: 25-1800
• Device Lot Number: 2047392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention