MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL PWR HIGH SPEED DRILL; SAW, POWERED, AND ACCESSORIES

Model Number	7209391S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the drill froze and got hot.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and no deficiencies were observed.A functional evaluation revealed that the device pulls a current but will not operate and becomes excessively hot.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The complaint was verified and the root cause was associated with component failure.Factors which could have contributed to the reported event, include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time.A blade stall condition can result in increased current draw from the control unit which will heat the motor and hand piece housing.No containment or corrective actions are recommended at this time.

• Brand Name: SVCE REPL PWR HIGH SPEED DRILL
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 12291493
• Report Number: 1643264-2021-02248
• Device Sequence Number: 4868425
• Product Code: HAB
• UDI-Device Identifier: 03596010498014
• UDI-Public: 03596010498014
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 7209391S
• Device Catalogue Number: 7209391S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1