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

Model Number	3866
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
One 012045 duckling upbiter punch basket returned.This is a twelve year old reusable instrument.The device is partially disassembled but does not display signs of aggressive use.Visual observations show typical scratches and dings on the jaw and other surface locations.The actuator is no longer engaging with the front end or the finger loop, therefore the jaw mechanics are not functioning.No root cause related to the manufacturing of this device can be established.

• Brand Name: PCH BSKT DCKLING UPBTR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7644205
• Report Number: 1219602-2018-00837
• Device Sequence Number: 13521751
• Product Code: NBH
• UDI-Device Identifier: 03596010120441
• UDI-Public: (01)03596010120441(10)999
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2018

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: 3866
• Device Catalogue Number: 012045
• Device Lot Number: 999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 07/19/2018; 07/19/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 07/20/2018; 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1