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	12/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during the rotator cuff arthroscopy procedure, the specialist was passing a suture through the properly mounted first-pass.At the moment of passing the point, the clamp of the needle and suture capture failed and fractured in its upper part.All the broken pieces that were inside the patient were removed and a s+n back up product was used to finish the procedure.Non-significant delay was reported, and no other complications were reported.Patient's health condition is stable.
Additional Manufacturer Narrative
B5 was updated.
Event or Problem Description
It was reported that during the rotator cuff arthroscopy procedure, the specialist was passing a suture through the properly mounted first-pass.At the moment of passing the point, the clamp of the needle and suture capture failed and fractured in its upper part.All the broken pieces that were inside the patient were removed using a grasper clamp and a s+n back up product was used to finish the procedure.Non-significant delay was reported, and no other complications were reported.Patient's health condition is stable.
Additional Manufacturer Narrative
The reported device 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 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states per case details, all the pieces were retrieved from the patient.The procedure was completed with a less than or equal to 30 minutes delay, using a s+n back-up device.No further complications were reported.Further patient impact beyond that which has already been reported cannot be determined.No further medical assessment is warranted at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include:1) excessive force.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.

• 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: 13314422
• Report Number: 3006524618-2022-00027
• Device Sequence Number: 4761108
• Product Code: NBH
• UDI-Device Identifier: 00817470000184
• UDI-Public: 00817470000184
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 11/28/2022

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: 06/23/2024
• Device Model Number: 22-4036
• Device Catalogue Number: 22-4036
• Device Lot Number: 2076741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2021
• Supplement Date Received by Manufacturer: 01/24/2022; 11/23/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 01/26/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female