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

Catalog Number 22-4038

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/09/2020

Event Type  malfunction  

Event Description

It was reported that when using the device during a shoulder surgery, the retractable needle did not retract when it was located at the shoulder cuff.The surgeon was able to remove the medical device carefully without severing the shoulder cuff.The procedure was completed with the same device.It is unknown if there was a delay in the case.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that when using the device during a shoulder surgery, the retractable needle did not retract when it was located at the shoulder cuff.The surgeon was able to remove the medical device carefully without severing the shoulder cuff across the surgical approach.However, besides the needle perforation, there was damage to subcutaneous and muscle non-target tissues.The procedure was completed with the same device and no significant delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10.Additional information in b5.

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.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.-tissue thickness may affect suture placement including stitch depth and needle entry point.-ensure adequate visibility when using the device.Should the needle tip become lodged (e.G., in bone), the needle should be disengaged by retracting it into the suture passer.Twisting or bending of the needle to dislodge the needle tip may result in breakage of the needle and needle parts may not be retrievable.Visual inspection shows no manufacturing abnormalities on the device.The instrument was returned with a closed top bracket which could not be opened; the needle is bent.The first step of the trigger is stuck; releasing is not possible; the device was dissected and a jam was indicated; a bent pin was found ; further tests were not possible due to the damage.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.No containment or corrective actions are recommended at this time.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: 10356926
• MDR Text Key: 201404019
• Report Number: 3006524618-2020-00568
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Catalogue Number: 22-4038
• Device Lot Number: 2042054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• 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
• Patient Weight: 85