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

Catalog Number 72200616

Device Problem Temperature Problem (3022)

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

Event Date 09/04/2018

Event Type  malfunction  

Event Description

It was reported that the hand piece was hot during the case.A backup device was available to complete the procedure with no delay or patient injuries.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.There was no relationship found between the returned device and the reported incident.The complaint of overheating could not be reproduced.A functional evaluation was performed and the mdu failed with a hand piece sensor fault.Cause of fault is a defective hall board.Motor and power cord passed functional testing.The complaint investigation has concluded that the cause of the hand piece sensor fault is a defective electronic component on the hall board.The complaint of overheating was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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: 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7889962
• MDR Text Key: 120969073
• Report Number: 1643264-2018-00721
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/26/2018
• Supplement Dates FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1