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

Catalog Number 72290128

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

International zip code: (b)(6).

Event Description

It was reported that during an arthroscopy, after triggering the firstpass mini in the joint -meniscus the jaw was broken and had to be removed with grasping forceps.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device reported, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.A review of manufacturing records for the reported lot number 2036951 found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.Review of the product ifu found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.Clinical evaluation was completed and concluded that smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.An exact root cause cannot be determined with confidence; however, 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 (3) damage or debris in the tip between passes.No containment or corrective actions are recommended at this time.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FIRSTPASS MINI STRAIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10063418
• MDR Text Key: 191250076
• Report Number: 3006524618-2020-00262
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694558
• UDI-Public: 885556694558
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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: 07/23/2022
• Device Catalogue Number: 72290128
• Device Lot Number: 2036951
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention