MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWERMINI, WITH HAND CONTROLS; SAW, POWERED, AND ACCESSORIES

Catalog Number	72201500
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Physical Resistance/Sticking (4012); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an arthroscopy of small joints of the hand, the motor drive unit, hand cntrl, pwrmx el and console were not functioning.The handpiece would only turn on, perform one rotation, and then stop.The procedure was resumed, after a delay greater than 30 min, with a change in surgical technique, an open surgery was performed.Additional anesthesia was required as consequence of the surgical prolongation & the patient health condition is stable.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alter the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an analysis of the customer provided image found a handpiece motor fault displayed on the screen.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that 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 or one or more of the motor phases shorting out.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual inspection revealed a broken lanyard, missing o-ring and a missing red dot indicator.A functional evaluation was performed on the returned device and found a stuck bottom button causing a handpiece error to display of the test d2.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with a mechanical component failure.Factors that could have contributed to the reported event include a buildup of corrosion/debris around the spring from cleaning chemical fluid ingression over time.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: DYONICS POWERMINI, WITH HAND CONTROLS
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24310372
• Report Number: 1643264-2026-00055
• Device Sequence Number: 4838066
• Product Code: HAB
• UDI-Device Identifier: 03596010621696
• UDI-Public: 3596010621696
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2026

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: 72201500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 06/03/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/19/2026; 06/10/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 60 KG