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

Model Number 72290128

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 04/13/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a medial meniscus posterior root tear, the right side of the catcher part in two (2) 'firstpass mini' came off while the meniscus was sutured.The procedure was completed with a s+n back up device.This resulted in a non-significant delay and no further complications were reported.

Event Description

It was reported that during a medial meniscus posterior root tear, the right side of the catcher part in two (2) 'firstpass mini' came off while the meniscus was sutured, the part were successfully removed from the patient.The procedure was completed with a s+n back up device.This resulted in a non-significant delay and no further complications were reported.

Event Description

It was reported that during a medial meniscus posterior root tear, the right side of the catcher part in the 'firstpass mini' came off while the meniscus was sutured.The broken part was removed from the patient.The procedure was completed with a s+n back up device.This resulted in a non-significant delay and no further complications were reported.

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient information was provided, thus a manufacturing record review could not be performed.Based on the information available, 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states it is noted within the attachments, no clinical/medical documentation is available.Based on the limited information provided the root cause of the catcher part of the firstpass mini could not be determined.Per case details, the broken piece was retrieved from the patient.The procedure was completed using a back-up device with a 30 minute delay.No patient injury or further complications were reported.Therefore, no further clinical/medical assessment is warranted at this time.There was no way to determine if the device contributed to the reported event.The complaint was not 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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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: 14288072
• MDR Text Key: 290782761
• Report Number: 3006524618-2022-00229
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 05/08/2022; 10/26/2022
• Supplement Dates FDA Received: 05/15/2022; 10/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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