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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS PWR HIGH SPEED DRILL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DYONICS PWR HIGH SPEED DRILL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7209391
Device Problems Failure to Power Up (1476); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that during an ip joint fusion the dyonics pwr high speed drill did not have any power. This event happened with a dyonics pwr high speed drill. Hand piece control error message was displayed in the screen. Instruments inside patient. Surgical delay of less than or equal to 30 minutes. Procedure finished with competitor device. No patient complications 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 NameDYONICS PWR HIGH SPEED DRILL
Type of DeviceSAW, POWERED, AND ACCESSORIES
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 
5123913905
MDR Report Key11722134
MDR Text Key247222566
Report Number1643264-2021-01533
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7209391
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
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

Patient Treatment Data
Date Received: 04/25/2021 Patient Sequence Number: 1
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