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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. O*MOTOR DRIVE UNIT EP-1,HAND SAW, POWERED, AND ACCESSORIES
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SMITH & NEPHEW, INC. O*MOTOR DRIVE UNIT EP-1,HAND SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205354
Device Problems Mechanical Jam (2983); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, during ankle stabilization, it was found that dyonics power handpiece could not rotate the blade, resulting in the damage of the handpiece. The malfunction was solved with a back up device with a delay shorter than 30 minutes. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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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 78735
5123913905
MDR Report Key10911781
MDR Text Key218711536
Report Number1643264-2020-01929
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
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 12/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205354
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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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