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

Catalog Number	23-2005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a shoulder scope (rc) case, the accu-pass direct crescent xl was being used on a loose pds 1.The hooked tip part of the passer broke halfway while pulling out of patient¿s shoulder.An ii was called to find the missing ¿hooked tip¿ which was found and removed from patient.Procedure was completed, after a non-significant delay, with a competitor device.No other complications were reported.
Additional Manufacturer Narrative
H10, h3, h6.The reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.The hook is detached from the tip of the device.Product was out of the original packaging.No packaging returned.A functional evaluation could not be conducted due to detached hook.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.A clinical review states this case reports the breakage of the accu-pass direct crescent tip.Undated intraoperative photos have been provided for review and confirms the reported breakage.Per case details, the tip was found and removed from patient.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A review of the customer provided images shows the device with the broken hook at the tip of the device.Also shows images of inside the patient and the retrieval of the hook.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.No containment or corrective actions are recommended 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: 13043727
• Report Number: 3006524618-2021-01062
• Device Sequence Number: 14811699
• Product Code: NBH
• UDI-Device Identifier: 00885556724569
• UDI-Public: 885556724569
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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
• Device Expiration Date: 03/11/2024
• Device Catalogue Number: 23-2005
• Device Lot Number: 2068372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown