MAUDE Adverse Event Report: ARTHROCARE CORP. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF

Catalog Number 22-4038

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2020

Event Type  malfunction  

Event Description

It was reported that during surgery the firstpass closed and locked shut.Upon removal from the patient the needle was outside of the top jaw and jammed the mechanism.The failure occurred with 2 different devices.There was a delay of under 30 min and the procedure was completed using a s+n backup device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, h6.The device reported, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.A review of manufacturing records for the reported lot number 2048570 found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force (2) tissue thickness (3) damage or debris on the device tip between passes.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DISPOSABLE FIRSTPASS SUTURE PASSER, SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10151413
• MDR Text Key: 195522684
• Report Number: 3006524618-2020-00370
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 22-4038
• Device Lot Number: 2048570
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/28/2020
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention