MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200616S

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the mdu was making a grinding noise and getting hot.A backup device was available to compete the procedure without delay or patient impact.

Manufacturer Narrative

Device investigation narrative - one service replacement powermax elite motor drive unit, part number 72200616s was received on (b)(6) 2017 and confirmed to be serial number (b)(4).Complaint of overheating and grinding noise was confirmed.Cause of overheating and grinding noise is a corroded motor/gearbox.The motor/gearbox was removed from the housing.The gearbox was removed from motor and motor tested good.The gearbox was found to be jammed and corroded internally.A review of the manufacturing records shows that this unit was released to distribution on or about (b)(6) 2015.The root cause of this event was identified to be associated with corrosion of the motor and gearbox assembly.A motor stall condition will result in increased current draw from the control unit which will heat the motor and hand piece housing.Factors which can contribute to gearbox corrosion include cleaning and sterilization methods and the chemicals involved.(b)(4).

• Brand Name: SVC REPL,MDU, HAND CNTRL, PWRMX
• 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 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6421662
• MDR Text Key: 70694380
• Report Number: 1643264-2017-00155
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2015
• 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