MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT DCKBL UPBTR 1.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number 012014

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2020

Event Type  malfunction  

Event Description

It was reported that the punch basket duckling was broken.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed the front end assembly had separated from the handle assembly.The set screw and the actuator were missing.The device was unable to be functionally evaluated due to the fractured front end assembly.A review of the device history 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 concluded this was an isolated issue.The complaint was confirmed.Factors that could have contributed to the reported event include the application of excessive force resulting in instrument failure.

• Brand Name: PCH BSKT DCKBL UPBTR 1.5MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10672014
• MDR Text Key: 211133557
• Report Number: 1219602-2020-01577
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010023360
• UDI-Public: 03596010023360
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/09/2021

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
• Device Operator: Health Professional
• Device Model Number: 012014
• Device Catalogue Number: 012014
• Device Lot Number: 50875210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1