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

Model Number 72290128

Device Problem Material Separation (1562)

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

Event Date 09/15/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a meniscal repair procedure, the upper jaw of the firstpass mini suture passer fell off when the meniscus was bit.The broken part was removed from the patient.The procedure was completed without delay using a smith and nephew back-up device.No further complications were reported.Further details are not available.

Manufacturer Narrative

H2: additional information ¿d4: lot number and expiration date, h4¿.

Manufacturer Narrative

H10: 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 instrument shows no manufacturing abnormalities.The suture capture is partially detached.Product was out of the original packaging.No packaging returned.A functional evaluation revealed the needle will deploy when trigger is initiated, the suture will pass, but the suture capture is partially detached.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 found similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states per case details, the upper jaw part of the firstpass mini suture passer ¿fell off when the meniscus was bit.¿ as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported is not anticipated as it was communicated, ¿the broken part was removed from the patient.¿ reportedly, the procedure was completed using a smith and nephew backup device without a reported injury or procedural delay.No harm has been alleged.Therefore, no further clinical/medical assessment is warranted.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: (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: 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: 15547356
• MDR Text Key: 301234728
• Report Number: 3006524618-2022-00434
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694558
• UDI-Public: 00885556694558
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2022

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 Model Number: 72290128
• Device Catalogue Number: 72290128
• Device Lot Number: 2080092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/06/2022; 12/12/2022
• Supplement Dates FDA Received: 10/12/2022; 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention