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	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a meniscal transplant, the accu-pass successfully passed first 3 sutures.On final attempt the needle was successfully pushed through the knee capsule but the hook was no longer attached to the device.The hook was successfully located in the fluid bag.Procedure finished with s&n backup device.Surgical delay of less than or equal to 30 minutes.No further complications to patient were reported due this event.
Additional Manufacturer Narrative
H10: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 for the reported batch number 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.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
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 instrument shows no manufacturing abnormalities.The needle is detached from the device.The product was out of the original packaging.No packaging returned.The device is single use only.Basic functional testing the thumb lever will move up and down, the needle will not deploy due to being detached.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.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
• MDR Report Key: 11965190
• Report Number: 3006524618-2021-00702
• Device Sequence Number: 4414904
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2021

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: 03/01/2022
• Device Catalogue Number: 23-2005
• Device Lot Number: 2029102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 10/06/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/20/2021; 10/19/2021
• 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: Required Intervention