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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER CABLE ASSEMBLY SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DYONICS POWER CABLE ASSEMBLY SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205788
Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2018
Event Type  malfunction  
Event Description
It was reported that the device was shorting. No patient injuries were reported. This failure was detected prior surgery. A backup was available.
 
Manufacturer Narrative
The device was received for evaluation. There was no relationship found between the returned device and the reported incident. An evaluation was performed by smith & nephew. A visual inspection observed bent pins in the handpiece connector. The pins were not touching other pins or the housing. A functional test revealed the bent pins prevented insertion of the handpiece. The pins were straightened and the cable retested, no shorts were observed. The complaint was not confirmed. Factors that could have contributed to the failure include excessive force, misalignment, or twisting of the connector during connection/disconnection to a handpiece.
 
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Brand NameDYONICS POWER CABLE ASSEMBLY
Type of DeviceSAW, POWERED, AND ACCESSORIES
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 west william cannon drive
austin, TX 78735
MDR Report Key7440250
MDR Text Key105905877
Report Number1643264-2018-00297
Device Sequence Number1
Product Code HAB
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 consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205788
Device Catalogue Number7205788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
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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