MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT DCKLING CRVD L; ACCESSORIES,ARTHROSCOPIC

Model Number	012046
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 012046 left curved duckling punch basket device returned.The complaint stated: ¿it was reported that the hinge broke with normal use.No patient injury¿.The device is one year old.It has been broken.The device was returned without the top cutting jaw piece.The outer shaft has a slight bow.The push rod/actuator is riding up and out of the channel at the distal tip.
Event or Problem Description
It was reported that the hinge broke with normal use.No patient injury was reported.

• Brand Name: PCH BSKT DCKLING CRVD L
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7195759
• Report Number: 1219602-2018-00083
• Device Sequence Number: 13706711
• Product Code: NBH
• UDI-Device Identifier: 03596010024022
• UDI-Public: (01)03596010024022(10)50692126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 012046
• Device Catalogue Number: 012046
• Device Lot Number: 50692126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1