MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINI MOTOR DRIVE UNIT, EP-1,; SAW, POWERED, AND ACCESSORIES

Model Number	7205357
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hand piece of the mini motor did not work during the surgery.The pedal was activated and the console looked as if it was working but the blade did not move, the pedal was changed, the blade was changed, but it did not work.After trying several times and disconnecting and reconnecting the console, it started to whistle and an engine error sign came out.Doctor then decided to perform an open surgery to complete the procedure.No patient injuries were reported.
Additional Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Mdu failed for motor stall error and overheating.Cause of motor stall and overheating is a jammed motor/gearbox.The motor/gearbox assembly could not be removed from the housing for further assessment because this type of mdu has the motor/gearbox potted inside of housing.The complaint was confirmed and the root cause has been determined to be a jammed motor/gearbox assembly.Factors which can contribute to jammed motor/gearbox include cleaning and sterilization methods and the chemicals involved.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: MINI MOTOR DRIVE UNIT, EP-1,
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 6976526
• Report Number: 1643264-2017-01025
• Device Sequence Number: 11062099
• Product Code: HAB
• UDI-Device Identifier: 03596010251800
• UDI-Public: (01)03596010251800
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2017

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
• Operator of Device: Health Professional
• Device Model Number: 7205357
• Device Catalogue Number: 7205357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1