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

Catalog Number	7209391
Medical Device Problem Codes	Failure to Power Up (1476); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an ip joint fusion the dyonics pwr high speed drill did not have any power.This event happened with a dyonics pwr high speed drill.Hand piece control error message was displayed in the screen.Instruments inside patient.Surgical delay of less than or equal to 30 minutes.Procedure finished with competitor device.No patient complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).H6: the reported device, used 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.No containment or corrective actions are recommended at this time.A functional evaluation revealed a blade stall error message and excessive heat produced from the handpiece.An investigation performed by the supplier revealed the device failed the torque test and has a grinding noise.The complaint was confirmed and the root cause was associated with a mechanical 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.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 instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• Brand Name: DYONICS 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: 11722134
• Report Number: 1643264-2021-01533
• Device Sequence Number: 19744572
• Product Code: HAB
• UDI-Device Identifier: 03596010466167
• UDI-Public: 3596010466167
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7209391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 04/25/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention