MAUDE Adverse Event Report: ARTHROCARE CORP. QFIX 1.8 MINI SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72290123

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

Event Type  Injury  

Event Description

It was reported that the q-fix mini all-suture anchor was stuck in the driver after deploying the anchor and trying to remove the driver, there is no information regarding how the procedure was completed, no patient injury, delay or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3,h6: the device used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records for the device 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 review of the instructions for use found: do not implant the anchor in poor quality bone or where bone quantity is limited.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.Care must be taken to not create too deep or too shallow a bone hole.Do not use excessive force or pound the inserter into the bone hole.Be sure to advance the inserter fully into the bone hole.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) misalignment of implant and inserter (4) wrong size hole.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: QFIX 1.8 MINI 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: 10463214
• MDR Text Key: 204685799
• Report Number: 3006524618-2020-00689
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556662618
• UDI-Public: 00885556662618
• Combination Product (y/n): N
• PMA/PMN Number: K172165
• 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: 10/01/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: 72290123
• Device Catalogue Number: 72290123
• Device Lot Number: 2045005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention