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

Model Number 72290123

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that during a procedure, the device was described as "1.8 mm q-fix mini all-suture anchor, with one #2 magnumwire blue and white suture".However, for the q-fix device in the test group received by the center, the product name indicated on the labels was ¿suture anchor¿, information was inconsistent with product description in the protocol and the label of other product with the same specification.They continued to use the device.No delay or 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 h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation.A review of the device history records 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 a repeat issue.A review of the label found no issues.A relationship between the subject device and the reported event was determined.Visual inspection and functional testing could not be performed since the device was not returned for evaluation; however, the complaint was confirmed.The product was used in a clinical trial and the clinical team had no confirmed product name which resulted in the inconsistent name in chinese label and protocol.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: 11273603
• MDR Text Key: 231386554
• Report Number: 3006524618-2021-00135
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2021
• Device Model Number: 72290123
• Device Catalogue Number: 72290123
• Device Lot Number: 2017701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1