MAUDE Adverse Event Report: ARTHROCARE CORPORATION 1.8MM Q-FIX DISPOSABLE FLEXIBLE DRILL; BIT, DRILL

Model Number	72290118
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy, the q-fix disposable flexible drill broke without the surgeon noticing, therefore, the drill bit didn't bottom out and caused the q-fix suture anchor to not deploy when used.Non-significant delay was reported, and the procedure was finished with a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events in the past 12 months.The instructions for use were 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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that the patient impact beyond the reported flexible drill breakage, ¿drill bit didn¿t bottom out¿ and subsequent failure of anchor deployment cannot be determined.It is unknown whether the broken drill was retained or recovered.If a drill portion of the device, was retained inside of the patient¿s body, the potential for corrosion, micro-motion and/or migration, and local skin irritation/discomfort cannot be rule out.An analysis of the customer provided image did not find a broken q-fix disposable flexible drill, but it found debris near the device's tip.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: 1.8MM Q-FIX DISPOSABLE FLEXIBLE DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16064745
• Report Number: 3006524618-2022-00525
• Device Sequence Number: 15129742
• Product Code: HTW
• UDI-Device Identifier: 00885556657447
• UDI-Public: 00885556657447
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 05/14/2024
• Device Model Number: 72290118
• Device Catalogue Number: 72290118
• Device Lot Number: 2073396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 10/24/2023
• Date Device Manufactured: 05/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown