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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED POWERPRO PRO7020 ATTACHMENT SURGICAL DRILL ATTACHMENTS

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CONMED POWERPRO PRO7020 ATTACHMENT SURGICAL DRILL ATTACHMENTS Back to Search Results
Catalog Number PRO7020
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2018
Event Type  Malfunction  
Manufacturer Narrative

The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.

 
Event Description

The conmed sales representative reported that during a procedure the (b)(4) "sheared off during use, the gearing ended up on the or floor. " upon gathering additional information, it was reported part of the bur and attachment of the device was resting in the patient's hip, which were retrieved from the patient. The procedure was completed with no reported surgical delays. No patient injury was reported. This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.

 
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Brand NamePOWERPRO PRO7020 ATTACHMENT
Type of DeviceSURGICAL DRILL ATTACHMENTS
Manufacturer (Section D)
CONMED
11311 concept blvd.
largo FL 33773
Manufacturer (Section G)
CONMED
11311 concept blvd.
largo FL 33773
Manufacturer Contact
martha camacho urribarri
525 french road
utica, NY 13502
3156243051
MDR Report Key7592559
MDR Text Key111027339
Report Number1017294-2018-00074
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberEXEMPT
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 07/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPRO7020
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/29/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/02/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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