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

Catalog Number 22-4036

Device Problems Break (1069); Component Missing (2306); Detachment of Device or Device Component (2907)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3: the sample is under evaluation by the manufacturing site.

Event Description

It was reported that during a shoulder arthroscopy, during the assembly of the firstpass needle to the clamp, it was observed that the plate (step 1) was disassembled from the attachment and was missing the assembly hook at the tip.The procedure was completed with a non-significant delay using a s+n back up device.No further complications were reported.Preliminary results of investigation have concluded that was found that the hook on the tip has been broken off.

Manufacturer Narrative

H6: the reported device was received for evaluation.A visual inspection revealed the device was returned in original packaging with the batch number of the complaint on the label.The suture capture was returned off of the insertion tool.There is bio debris on the suture capture.The hook on the tip has been broken off.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.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 has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device.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 CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18267461
• MDR Text Key: 329734641
• Report Number: 3006524618-2023-00486
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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 Catalogue Number: 22-4036
• Device Lot Number: 2091134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 35 KG