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

Catalog Number 22-4038

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a rotator cuff repair, the firstpass was being used to pass ultratape through the supraspinatus tendon.The trap doors used to capture the tape came apart and were free in the joint.An arthroscopic grasper was used to retrieve the components inside the patient and a new firstpass was opened in which the case was completed with no further issues.Non-significant delay was reported, and no other complications were reported.

Manufacturer Narrative

H3, h6: ¿the reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.The suture capture is completely detached.Product was out of the original packaging.No packaging returned.A functional evaluation revealed the needle will deploy when trigger is initiated, sutures were not able to be tested for passage due to break.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states per the complaint details, ¿no consent been granted for patient¿s details and medical history.¿ therefore, without relevant clinical information a thorough medical investigation cannot be rendered nor can the root cause of the reported failure be determined.Based on the limited information provided, the surgeon used an arthroscopic grasper to retrieve the components from inside of the patient and a new firstpass was used to completed the surgery with no further issues and a non-significant delay was reported.Since no other complications were reported, no further clinical/medical assessment is warranted at this time.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: excessive force; tissue thickness; damage or debris on the device tip between passes.No containment or corrective actions are recommended at this time.".

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12774453
• MDR Text Key: 280511687
• Report Number: 3006524618-2021-01006
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4038
• Device Lot Number: 2071688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Date Device Manufactured: 04/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention