MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER CONTROL UNIT; ARTHROSCOPE

Model Number	7205841
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during a surgery the control unit was defective.The procedure was completed without a significant delay.A competitor device was used.No patient injury or other 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
Internal complaint reference: (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A review of the operations/service manual found that only smith & nephew dyonics¿ disposable endoscopic blades can be used with the smith & nephew dyonics power shaver system.Check that the electrical equipment is properly grounded (i.E., plugs contain a ground prong).Grounding reliability can be achieved only when the dyonics power shaver system is connected to an equivalent ac power receptacle marked ¿hospital only¿ or ¿hospital-grade.¿ when connecting peripheral and accessory devices to the dyonics power shaver system, use only cables that have been validated for use with the system.Nonvalidated cables may damage the control unit and create electrical hazards.The use of non-validated cables will void the warranty.A relationship, if any, between the subject device and the reported event could not be determined.

• Brand Name: DYONICS POWER CONTROL UNIT
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11130810
• Report Number: 1643264-2021-00058
• Device Sequence Number: 3334746
• Product Code: HRX
• UDI-Device Identifier: 03596010406200
• UDI-Public: 03596010406200
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2021

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 Model Number: 7205841
• Device Catalogue Number: 7205841
• Device Lot Number: WA18992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1