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

Catalog Number 22-4036

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during a surgery, the clamp of the needle and suture capture device was mounted, the suture point was passed through the supra-spinal but the suture plate on the other side of the tissue was not gripping, so the suture passed but the device was no capturing it.The procedure was successfully completed without a significant delay using a backup device.No patient injury or complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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 concluded this was a repeat issue.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Manufacturer Narrative

The reported device was received for evaluation.A visual inspection showed the device was returned in original packaging with the batch number of the complaint on the label.The suture capture was returned in the #4 suture remover device.The suture capture had bio debris in the teeth.No other visible deficiency.The suture passer was returned in the #4 suture passer remover.No visible deficiency.A functional evaluation using a reference firstpass and reloading the complaint suture capture and suture passer showed the suture passer passed the suture through the suture capture which caught and held the suture.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 no 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 an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: NEEDLE AND SUTURE CAPTURE
• Type of Device: 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: 11737058
• MDR Text Key: 248033349
• Report Number: 3006524618-2021-00520
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00817470000184
• UDI-Public: 00817470000184
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Catalogue Number: 22-4036
• Device Lot Number: 2062152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 05/27/2021; 10/30/2023
• Supplement Dates FDA Received: 05/28/2021; 11/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male