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

Catalog Number 25-1800

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/27/2020

Event Type  Injury  

Event Description

It was reported that during the surgery, the suture of the q-fix anchor broke immediately when it was pulled after implant deployment.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during the surgery, the suture was broken immediately when it was pulled after implant deployment.The broken suture was removed and a smith and nephew back-up device was available to complete the surgery.No other complication or delay were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was returned for evaluation.There was no 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 isolated event.A review of risk management files found that the reported failure was documented appropriately.-do not implant the anchor in poor quality bone or where bone quantity is limited.Incomplete insertion or poor bone quality may result in implant pullout or suture breakage.- do not bend, apply excessive torque, or twist the inserter handle during and after insertion as damage to the implant or incomplete insertion may result.Clinical/medical evaluation was completed and concluded that there was no patient harm or significant delay reported.Therefore, since no patient harm is being alleged, no further assessment is warranted at this time.Visual inspection shows a deployed device.The shaft is bent and the implant is detached.No suture is available.There are no manufacturing abnormalities visually observed.The returned device is a single used device and cannot be functional tested.The deployment knob can rotate easily in both directions.The complaint was not confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) incorrect suture loading.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: 10418387
• MDR Text Key: 203277419
• Report Number: 3006524618-2020-00647
• 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,Followup
• Report Date: 09/28/2020

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: 08/06/2022
• Device Catalogue Number: 25-1800
• Device Lot Number: 2038539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 08/24/2020; 09/24/2020
• Supplement Dates FDA Received: 08/27/2020; 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention