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

Catalog Number 22-4038

Device Problem Fracture (1260)

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

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a repair of the rotator cuff by arthroscopy, when the firstpass suture passer was used, it fractured, leaving clamp debris in the joint.The clamp was no longer functional and back-up device had to be used to complete the procedure without delay.All the debris were removed with a prehensive clamp and were pre-disinfected.No further complications were reported.

Manufacturer Narrative

H3, h6: a device deficiency was identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A clinical review states that undated photos of the device were provided for review and confirms the reported breakage.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.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.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned device found that it is not in its original packaging.The suture trap of the jaw is fractured away and was not returned and the inner curve of the curved needle is fractured.The device has debris on it.Undated photos of the device were provided for review and confirms the reported breakage.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was confirmed, and the root cause was associated with unintended use of the device.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.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16503680
• MDR Text Key: 310890152
• Report Number: 3006524618-2023-00082
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• 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: 2080238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2021
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 87 KG