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

Catalog Number 22-4038

Device Problem Material Separation (1562)

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

Event Date 07/19/2019

Event Type  malfunction  

Event Description

It was reported that during rotator cuff repair surgery, the self capture portion of the device, broke in three pieces and came off the device inside of the patient¿s shoulder.All pieces were recovered.A backup device was available to complete the procedure with no significant delay or patient injuries.

Manufacturer Narrative

The reported disposable firstpass suture passer device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿the self capture portion of the device, broke in three pieces and came off the device inside of the patient¿s shoulder.¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force.(2) tissue thickness (3) tip damaged between passes.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.The instructions for use states: 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.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

The reported disposable firstpass suture passer device, intended for use in treatment, was returned for evaluation.A relationship between the devices and reported incident was established.From the information provided, ¿the self capture portion of the device broke in three pieces and came off the device inside of the patient¿s shoulder.¿ customer¿s complaint was confirmed.Visual evaluation shows that the device suture trap is missing.No manufacturing discrepancies were observed.During functional evaluation the two step trigger performed as intended, the jaw could be opened and closed, and the needle could be extended without any issues.The needle went through a foam model and passed a stitch as intended.The suture capture shows no visual or functional discrepancies.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force, tissue thickness, and/or tip damaged between passes.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.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: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8883607
• MDR Text Key: 153989477
• Report Number: 3006524618-2019-00390
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2021
• Device Catalogue Number: 22-4038
• Device Lot Number: 2022636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR