MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE INSTRUMENT CURVED LEFT; ACCESSORIES,ARTHROSCOPIC

Model Number 72201186

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

It was reported that during arthroscopy, the arthropierce instrument's grabbing arm stopped closing in mid procedure.There was a delay of under 30 min, the procedure was completed with a change in technique using a competitor device (mitek cleverhook).No patient injury or 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 reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review for the reported batch number concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.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 relationship, if any, between the subject device and the reported event could not be determined.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.

• Brand Name: ARTHROPIERCE INSTRUMENT CURVED LEFT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10767698
• MDR Text Key: 214093962
• Report Number: 1219602-2020-01720
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010605610
• UDI-Public: 03596010605610
• 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: 06/14/2021

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: 72201186
• Device Catalogue Number: 72201186
• Device Lot Number: 50599989
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/01/2020
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention