MAUDE Adverse Event Report: ARTHROCARE CORP. QFIX 1.8 MINI SUTURE ANCHOR DISP KIT; ACCESSORIES,ARTHROSCOPIC

Model Number	72290125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder surgery for bicep tenodesis, when the q-fix drill was inserted and advanced through the drill guide, it became lodged in the guide and broke above the guide.All pieces were removed.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 since the product was not returned for evaluation.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 complaint history review concluded this was an isolated event.Please refer to the instructions for use for recommendations on device usage.A review of risk management files found that the reported failure was documented appropriately.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) excessive force.(2) improper alignment of the handle.There are no indications to suggest 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.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned device shows the device is used and has been broken.A functional evaluation is not conducted due to damaged device.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 review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) improper alignment of the handle.No containment or corrective actions are recommended at this time.

• Brand Name: QFIX 1.8 MINI SUTURE ANCHOR DISP KIT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10660176
• Report Number: 3006524618-2020-00868
• Device Sequence Number: 3146293
• Product Code: NBH
• UDI-Device Identifier: 00885556662632
• UDI-Public: 00885556662632
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: 72290125
• Device Catalogue Number: 72290125
• Device Lot Number: 2049139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/03/2020; 05/05/2021
• Initial Report FDA Received Date: 10/11/2020
• Supplement Report FDA Received Date: 11/04/2020; 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention