MAUDE Adverse Event Report: ARTHROCARE CORPORATION DFP SUTURE PASSER STANDARD

Catalog Number	22-4039
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that during an arthroscopy procedure, the tip of the suture passer broke off when the needle pierced.The procedure was successfully completed with non-significant surgical delay using a back-up device.No further complications were reported.
Event or Problem Description
It was reported that during an arthroscopy procedure, the tip of the suture passer broke off when the needle pierced.All broken parts were removed from the patient using barrel forceps.The procedure was successfully completed with non-significant surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in original packaging.The suture capture is missing from the upper jaw and was not returned.There are no other discrepancies.A functional evaluation showed that pulling the lever closes and locks the jaws.Pulling the lever and trigger simultaneously deploys the suture passer through the empty window of the closed jaw.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 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 has been associated with unintended use of the device.Factors that could have contributed to the failure include tissue thickness, damage or debris on the device tip between passes.No containment or corrective actions are recommended at this time.

• Brand Name: DFP SUTURE PASSER STANDARD
• Common Device Name: PASSER
• 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: 17652729
• Report Number: 3006524618-2023-00339
• Device Sequence Number: 17706512
• Product Code: HWQ
• UDI-Device Identifier: 00885556724552
• UDI-Public: 885556724552
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 06/10/2024
• Device Catalogue Number: 22-4039
• Device Lot Number: 2075000
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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 Age: 33 YR
• Patient Sex: Male