MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; PASSER

Catalog Number 22-4038

Device Problem Break (1069)

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

Event Date 12/29/2018

Event Type  malfunction  

Event Description

It was reported that during a rotator cuff surgery the suture passer broke.A backup device was used to complete the surgery.No significant delay or patient injury reported.

Event Description

It was reported that during a rotator cuff surgery the suture passer broke while dr was tying a knot from outside going to the inside of the shoulder.A new whole was made for the new anchor.A backup device was used to complete the surgery.No significant delay or patient injury reported.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was no relationship found between the device and the reported incident.Visual inspection shows a device which was returned deployed with an open bracket.The self-capturing part is bent/damaged, contaminated with unknown substances and detached.It was retuned in a separate minigrip bag.There were no manufacturing abnormalities found on the device; during functional evaluation the two step trigger is working as intended; the bracket closed and the needle was deployed as specified despite the missing and damaged self-capturing; the complaint was not verified and the root cause could not be determined with certainty.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are outlined in the precautionary states in the instruction for use provided with the device associated with set-up and use of the device; a possible factor for the complaint could be if (1) excessive force is be applied to the device when manipulating soft tissue, bone, or hard objects (2) thickness of tissue.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that, during a rotator cuff repair surgery, the suture passer broke while the physician was tying a knot from outside going to the inside of the shoulder.A new hole was made for the new anchor.A back-up device was used to complete the surgery with no delay.No patient injury was reported.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8250930
• MDR Text Key: 133213595
• Report Number: 3006524618-2019-00019
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• Device Catalogue Number: 22-4038
• Device Lot Number: 2017330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1