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

Catalog Number 22-4038

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 06/18/2020

Event Type  Injury  

Event Description

It was reported that the during rotator counter pair, the jaw of the first pass suture was not working.No significant delay and a competitor device was used to complete the procedure.No 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 h3, h6: the device intended to be used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was a repeat issue.Clinical evaluation was completed and concluded that based on the information provided there was no significant delay nor patient injury/impact; therefore, no further medical assessment is warranted at this time.A review of the instructions for use found: -as with any surgical instrument, care should be taken to ensure that excessive force is not placed on the device.- do not use this device as a lever for manipulating hard tissue or bone.Excessive force should not be applied to the device when manipulating soft tissue, bone, or hard objects.Misuse of this device may result in bent or broken distal tip or jaws.- when passing suture multiple times always check the tip of the device for damage or debris between passes.Clear any visible debris between passes.Discontinue use if the device becomes damaged between passes.Factors that could have contributed to the reported event include: (1) excessive force (2) misalignment of inserter and implant during and after insertion.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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: 10286364
• MDR Text Key: 199231779
• Report Number: 3006524618-2020-00501
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• 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: 08/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Catalogue Number: 22-4038
• Device Lot Number: 2047480
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 08/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention