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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. SVCE REP DYONICS POWER II CONTROL UNIT ARTHROSCOPE Back to Search Results
Model Number 72200873S
Device Problems Communication or Transmission Problem (2896); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4). The reported device, intended for use in treatment, was received for evaluation. A visual inspection was performed on the product and no issue was observed. There was a relationship found between the returned device and the reported incident. Product failed functional testing with handpiece stall error. Cause of errors is a defective electronic component. The complaint was confirmed and the root cause has been determined to be a defective electronic component. 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 complaint history review concluded this was a repeat issue.
 
Event Description
It was reported that during set up or inspection for an unknown procedure the port a is not driving the hand piece and the port b is 90 degrees off in the dyonics power ii control unit. The procedure was successfully completed without delay using a back-up device. 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.
 
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Brand NameSVCE REP DYONICS POWER II CONTROL UNIT
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 Key11479024
MDR Text Key239692810
Report Number1643264-2021-00993
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200873S
Device Catalogue Number72200873S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
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?
Type of Device Usage Unkown

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