MAUDE Adverse Event Report: ARTHROCARE CORPORATION FIRSTPASS SUTURE PASSER

Model Number 22-4035

Device Problem Fracture (1260)

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

Event Date 04/01/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a rotator cuff repair, when the firstpass suture passer was used, its mandible fractured, which prevented the proper passage of the stitch.The procedure was completed using a back-up device.It is unknown if there was a delay.No further complications were reported.The patient status is stable.

Event Description

It was reported that during a rotator cuff repair, when the firstpass suture passer was used, its mandible fractured, which prevented the proper passage of the stitch.All parts were removed, they came out complete upon device's removal.The procedure was completed without delay using a back-up device.No further complications were reported.The patient status is stable.

Manufacturer Narrative

H2: additional information on b5 and h6 (health effect - impact code).

Manufacturer Narrative

H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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.An analysis of the customer provided image found the mandible of the first pass suture passer fractured.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.¿se pega el roi¿.

• Brand Name: FIRSTPASS SUTURE PASSER
• 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: 16792901
• MDR Text Key: 313805042
• Report Number: 3006524618-2023-00158
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470000160
• UDI-Public: 00817470000160
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22-4035
• Device Catalogue Number: 22-4035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female