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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. CONTROL UNIT, DYONICS 25 ARTHROSCOPE Back to Search Results
Catalog Number 7211010
Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2017
Event Type  malfunction  
Manufacturer Narrative
There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the product and identified a peeling front overlay. A functional evaluation performed on the device revealed the pressure transducer p2 is out of pressure specification. The complaint was verified and the root cause has been associated with an electrical component failure. Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include an electrical component failure or a defective pressure transducer. A review of the device history record was performed which confirmed no inconsistencies.
 
Event Description
It was reported that the dyonics 25 control unit was not working properly and the flow was very slow during a shoulder procedure. There was no backup device available, so the surgeon completed the procedure manually. No patient injuries or complications were reported.
 
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Brand NameCONTROL UNIT, DYONICS 25
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 w william cannon dr.
austin, TX 78735
5123585706
MDR Report Key6266149
MDR Text Key115123047
Report Number1643264-2017-00049
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K051326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7211010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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