MAUDE Adverse Event Report: ARTHROCARE CORP. NEEDLE AND SUTURE CAPTURE; ACCESSORIES,ARTHROSCOPIC

Model Number	22-4036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during an arthroscopy setup, the needle and suture capture broke during the installation into the firstpass.The procedure was completed with a backup device.No delay.As this failure occurred during setup, the patient was not harmed.
Additional Manufacturer Narrative
H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.The description, the needle and suture capture broke during the installation into the firstpass does not indicates a device physical breakage and is considered a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection showed the device was not received in any original packaging.The suture capture was not returned.The suture passer has been deployed and was returned taped to a shipper card.There is no visible deficiency.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 similar reported events.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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include excessive force, tissue thickness or damage or debris on the device tip between passes.No containment or corrective actions are recommended at this time.This event has been re-evaluated for mdr reporting and it was determined that this is a reportable event.
Event or Problem Description
It was reported that, during an arthroscopy setup, the needle of the needle and suture capture device broke during the installation into the firstpass.The procedure was completed with a backup device.No delay.As this failure occurred during setup, the patient was not harmed.

• Brand Name: NEEDLE AND SUTURE CAPTURE
• 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: 12787962
• Report Number: 3006524618-2021-01010
• Device Sequence Number: 17347333
• Product Code: NBH
• UDI-Device Identifier: 00817470000184
• UDI-Public: 00817470000184
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: 22-4036
• Device Catalogue Number: 22-4036
• Device Lot Number: 2071573
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 11/17/2021; 11/02/2023
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 11/17/2021; 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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
• Patient Sex: Unknown