MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOT DR UNIT HNDCONT POWERMAX ELITE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	72200872
Medical Device Problem Codes	Overheating of Device (1437); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates 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 conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that the mdu was getting so hot that the staff could not hold it.It is unknown whether the event happened during surgery, if there was patient involvement, if there was a back-up device available or if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: additional and corrected information in b3, b5, e1, e2, e3 and h6: health effect - impact code.
Event or Problem Description
It was reported that, during an unknown procedure, the mdu was getting so hot that the staff could not hold it.There was no damaged caused by the overheating device.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H2: corrected data on g2 & additional information in h6 - medical device problem code.H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluation was performed on the returned device and found device grew warm and a blade stall error message was found.It was also noted device ma was above 960.Further investigation revealed stiffness in the drive fork when rotated.The stiffness have been determined to be related to the reported event 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 found similar reported events.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 has been associated with component failure.Factors that could have contributed to the failure include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or a short in the power cord.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: MOT DR UNIT HNDCONT POWERMAX ELITE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 21972291
• Report Number: 1643264-2025-00150
• Device Sequence Number: 20639810
• Product Code: HWE
• UDI-Device Identifier: 03596010618894
• UDI-Public: 3596010618894
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2025

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: 72200872
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 06/04/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/14/2025; 06/09/2025
• 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