MAUDE Adverse Event Report: ARTHROCARE CORP. ACCU-PASS DIRECT CRESCENT XL; ACCESSORIES,ARTHROSCOPIC

Catalog Number	23-2005
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy procedure, the surgeon passed the accupass direct crescent xl through the labrum and when he removed the device from the labrum having passed the suture, it was observed that the tip of the hook was missing; tip was removed from patient by suction.The procedure was completed with a back-up device and a delay greater than 30 minutes was reported.No patient complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.The tip of the hook is detached.Product was out of the original packaging.No packaging returned.A functional evaluation could not be conducted due to hook being broken.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) excessive force.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 found similar reported events.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.Our clinical investigation concluded: a clinical review states per case details, the broken tip was retrieved from the patient.The procedure was completed using a back-up device.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Per e-mail communication, the patient status was reported as ¿ok.¿ since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.

• Brand Name: ACCU-PASS DIRECT CRESCENT XL
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13342400
• Report Number: 3006524618-2022-00029
• Device Sequence Number: 17133145
• Product Code: NBH
• UDI-Device Identifier: 00885556724569
• UDI-Public: 885556724569
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 07/08/2024
• Device Catalogue Number: 23-2005
• Device Lot Number: 2076824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: Female