MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS MINI STRAIGHT; ACCESSORIES,ARTHROSCOPIC

Model Number 72290128

Device Problems Break (1069); Separation Problem (4043)

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

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during use in an arthroscopy, the mouth of the firstpass mini broke off.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during use in an arthroscopy, the mouth of the firstpass mini broke off.All the broken pieces were removed from the patient with a grasper.A delay less or equal than 30 minutes were reported and the procedure was finished with a smith and nephew back up device.No patient injury or other complications were reported.

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 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 states it was communicated via e-mail that the broken pieces were retrieved from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or misuse of the device.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation showed the suture capture teeth are no longer in the upper jaw.A deformed suture capture was returned taped to the handle.There is bio debris in the jaw and on the insertion rod.A functional evaluation showed the jaws opened and closed as intended.The suture passer deployed as intended.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 review of risk management files found that the reported failure was documented appropriately.A clinical review states it was communicated via e-mail that the broken pieces were retrieved from the patient.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed and the root cause was associated with unintended use of the device.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force (2) tissue thickness.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

Internal complaint reference: (b)(4).

• Brand Name: FIRSTPASS MINI STRAIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 12374373
• MDR Text Key: 268364299
• Report Number: 3006524618-2021-00877
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694558
• UDI-Public: 00885556694558
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2023
• Device Model Number: 72290128
• Device Catalogue Number: 72290128
• Device Lot Number: 2063357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 10/07/2021; 11/01/2021; 07/24/2023; 07/24/2023
• Supplement Dates FDA Received: 10/08/2021; 11/19/2021; 07/26/2023; 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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