MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CHONDRAL PICK 40 DEG SMALL DIA; ACCESSORIES,ARTHROSCOPIC

Model Number 72201885

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2020

Event Type  malfunction  

Event Description

It was reported that during surgery, when the 40 degree chondral pick was used, the device was brittle and the tip of it bent easily 90 degree.It is unknown whether there was a delay in the case.The procedure was completed with a competitor device.No patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the reported 40 degree chondral pick, used in treatment, has been returned for evaluation.Visual assessment of the device confirmed the reported complaint.The distal tip of the pick has been bent to 90 degrees.The material condition was tested and confirmed to be within print specification.The condition of the device indicates it was subjected to excessive force during use.Per the devices instruction for use ¿excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips¿.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: CHONDRAL PICK 40 DEG SMALL DIA
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9772665
• MDR Text Key: 181965174
• Report Number: 1219602-2020-00443
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010608291
• UDI-Public: 03596010608291
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201885
• Device Catalogue Number: 72201885
• Device Lot Number: 50693308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1