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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION POWERPRO 5:1 ZIMMER/HUDSON REAMER ATTACHMENT SAW, POWERED, AND ACCESSORIES

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CONMED CORPORATION POWERPRO 5:1 ZIMMER/HUDSON REAMER ATTACHMENT SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO6047
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2020
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. This issue will continue to be monitored through the complaint system to assure patient safety.

 
Event Description

The customer reported that the device, (b)(4), was being used during surgery on (b)(6) 2020 when the device "came apart". Upon further assessment, all pieces were retrieved, and there was no report of injury to the patient. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

 
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Brand NamePOWERPRO 5:1 ZIMMER/HUDSON REAMER ATTACHMENT
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
CONMED CORPORATION
11311 concept blvd.
largo FL 33773
Manufacturer (Section G)
CONMED CORPORATION
11311 concept blvd.
largo FL 33773
Manufacturer Contact
robin drum
11311 concept blvd.
largo, FL 33773
8653881978
MDR Report Key10758080
MDR Text Key213871315
Report Number1017294-2020-00467
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/05/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberPRO6047
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/17/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
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 Unkown

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