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

Catalog Number 22-4038

Device Problem Mechanical Problem (1384)

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

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that during a shoulder cuff repair, when doctor triggered the firstpass in the joint and pierced through the cuff, the needle shifted.Because of this the two jaws could no longer opened, by using an aid to push the two jaws apart further damaged to the cuff was able to be prevented.The procedure was completed with the same device and no significant delay or further complications 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 not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records 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 issue.A review of the instructions for use found that excessive force can result in device failure.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows a jammed trigger with the needle fully deployed outside of the jaw and suture capture.No manufacturing abnormalities.A functional evaluation was limited due to the trigger being jammed.The trigger was unable to unjam and the needle would not return to starting position.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 review of risk management files found that the reported failure was documented appropriately.A clinical review noted the patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) 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
• MDR Report Key: 11390916
• MDR Text Key: 233963202
• Report Number: 3006524618-2021-00251
• 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,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Catalogue Number: 22-4038
• Device Lot Number: 2059325
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention