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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL CONTROL UNIT DYONICS 25 ARTHROSCOPE

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SMITH & NEPHEW, INC. SVCE REPL CONTROL UNIT DYONICS 25 ARTHROSCOPE Back to Search Results
Model Number 7211010S
Device Problems Communication or Transmission Problem (2896); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4). The reported device, intended for use in treatment, was received for evaluation. There was no relationship found between the returned device and the reported incident. A visual inspection was performed on the product and observed no issues. A functional evaluation revealed transducer p1 failed the high pressure test. The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process. Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.
 
Event Description
It was reported that, during setup for surgery, the "control unit, dyonics 25" was not reading the cartridge. A backup device was available to complete the procedure. There were no procedural delays and no patient injuries or other complications were reported. Results of investigation have concluded that this unit transducer p1 failed high pressure test which makes it a reportable event.
 
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Brand NameSVCE REPL CONTROL UNIT DYONICS 25
Type of DeviceARTHROSCOPE
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
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11850043
MDR Text Key251452954
Report Number1643264-2021-01904
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7211010S
Device Catalogue Number7211010S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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