MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES

Catalog Number ED72200616

Device Problems Overheating of Device (1437); Smoking (1585); Device Displays Incorrect Message (2591)

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

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the dyonics generator alarm sounded.A short circuit error was present as well as smoke.The unit was unplugged immediately.The handpiece cord was hot to touch.No patient or user injury reported.This did not result in any delays.A backup device was available to complete the procedure.

Manufacturer Narrative

One service replacement powermax elite motor drive unit, part number (b)(4) was received on (b)(6) 2017 and confirmed to be serial number (b)(4).There was a relationship found between the returned device and the reported incident.Unit was powered on using the appropriate test equipment and it failed with "short circuit detected" error message and alarm.A kink was observed in the middle of the power cord and power cord grew hot.After troubleshooting, the cause of error was observed to be a defective power cord assembly.It was determined that the power cord has a shorted or open internal wire.Motor and hall board were tested and passed functional testing.The complaint investigation has concluded that this unit has succumbed to physical damage to power cord.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include a crushing or shear force induced on the cord inconsistent with normal use.A review of the manufacturing records shows that this unit was released to distribution on or about december 5, 2014.No containment or corrective actions are recommended at this time.

• Brand Name: MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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: james gonzales ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 6535633
• MDR Text Key: 74257073
• Report Number: 1643264-2017-00239
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ED72200616
• Device Lot Number: AAX 5824
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/01/2017
• Supplement Dates Manufacturer Received: 04/10/2017
• Supplement Dates FDA Received: 08/29/2017
• 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