MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE

Catalog Number 72200873

Device Problem Melted (1385)

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

Event Type  malfunction  

Event Description

It was reported that sectors of the mcb have melted, it has been overloaded.No case involved.No patient injury was reported.

Manufacturer Narrative

A visual inspection was performed on the product and no issue was observed.There was no relationship found between the returned device and the reported incident.Product failed to power up.Cause of power up failure is a dead power supply.A known good power supply was installed and unit powered up.Then the unit failed for ¿footswitch required¿ error message in port a only.When an mdu was inserted into port a the motor could not be activated.Cause of malfunction in port a is a defective electronic component on the main pcb part number.Also a resistor was burnt.Reason for electronic component failure is unknown but a shorted out mdu is a possibility.Product passed functional testing with a known good power supply and main pcb installed.The complaint investigation has concluded the cause of the failure to be a defective electronic component.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.

• Brand Name: DII CONTROLLER
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7286811
• MDR Text Key: 100733121
• Report Number: 1643264-2018-00156
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1