MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER SMALL BATTERY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	72204114
Medical Device Problem Codes	Failure to Shut Off (2939); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a foot surgery, the forward button of the dyonics handpiece was sticky but when it was released the handpiece did not shut off.The procedure was successfully completed without delay using a back-up device.No patient injury or complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).The reported device was received for evaluation.A visual inspection found cosmetic scratches, and the forward trigger stuck.A functional evaluation was performed by the supplier.The device failed testing due to the trigger is stuck in the housing.The device was inspected and found nicks in the trigger housing causing the trigger to get stuck, also the controller failed for high current and the lohet in the base is bad.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause was associated with unintentional use of the device.Factors that could have contributed to the reported event include an impact to the device and improper maintenance.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.A review of risk management files found that the reported failure was documented appropriately.No containment or corrective actions are recommended at this time.

• Brand Name: DYONICS POWER SMALL BATTERY HANDPIECE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11404873
• Report Number: 3003604053-2021-00066
• Device Sequence Number: 11904158
• Product Code: HWE
• UDI-Device Identifier: 00885554033458
• UDI-Public: 885554033458
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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 Catalogue Number: 72204114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown