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

Catalog Number 22-4038

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during an arthroscopy, a broken piece of metal was found inside the patient, the suture capture parts were broken.All pieces were recovered.The procedure was completed using a s&n back-up.There was a 10 minutes delay.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

The reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number 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 complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.Clinical evaluation was completed and concluded that based on the information provided, all of the broken pieces of metal were removed from inside of the patient.Per report, the procedure completed using an s&n backup device with a ten-minute delay.Since no additional complications were reported; no further, clinical/medical assessment is warranted at this time.Should additional medical information be provided, this compliant will be re-assessed.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.Excessive force can result in failure.-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.-tissue thickness may affect suture placement including stitch depth and needle entry point.-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.Visual inspection shows no manufacturing abnormalities on the device.The instrument was returned with an open top bracket, the device shows a broken-off part on the suture capture which was returned with the device in a separate pouch.An attempt was made to test the basic functions.The first step of the trigger performed as intended; the bracket was closed and the needle could be triggered as specified.The device is a single use device and could not be fully functional tested.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness.(3) damage or debris in the device tip between passes.There were no indications 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: 10275791
• MDR Text Key: 198870521
• Report Number: 3006524618-2020-00486
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2022
• Device Catalogue Number: 22-4038
• Device Lot Number: 2026115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention