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U.S. Department of Health and Human Services

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

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CONMED CORPORTATION POWERPRO 5:1 ZIMMER/HUDSON REAMER ATTACHMENT SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO6047
Device Problems Vibration (1674); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

As of this filing, the reamer attachment has not yet been returned for evaluation. A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.

 
Event Description

The distributor in (b)(4) reported that a hospital reported while using a powerpro 5:1 zimmer/hudson reamer this attachment had great wobbling compared to other attachments. The surgeon stated that the size of the acetabular reaming was one size larger because of this wobbling. According to the report, there was no patient injury and the procedure was completed using this device. The device is being returned to conmed for analysis and repair.

 
Manufacturer Narrative

The used reamer attachment was received for evaluation. A video clip was also sent in by the distributor demonstrating the wobble while using a drill with this attachment and a very long reamer. The initial evaluation of this returned device found no problem with the functioning of this attachment. Further testing was performed using a very long reamer. While testing using the very long reamer, wobbling was able to be duplicated. A component of this device was found to be dimensionally out of specification, when this component and another were replaced the wobbling was eliminated. An investigation remains in process. A review of the device history record for this device found no discrepancies during the manufacturing process that could have caused or contributed to this reported issue. A 2-year review of complaint history shows there has been a total of 2 complaints for the reported failure mode - wobbling. During this same 2-year time frame there were over (b)(4) units sold world-wide. To date, there have been no reports of serious injuries or death related to this reported issue or the use of this device. The instructions for use (ifu) provides the following precautions: this equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Read and follow all warnings, precautionary notices and instructions marked on the product and included in this insert. Handle all equipment carefully. If an attachment is dropped or damaged in any way, return it immediately for service. Prior to each use, inspect all equipment for proper operation and ensure all attachments and accessories are correctly and completely attached to the handpiece. Reaming and saw attachments are not designed to be used in any screw, tap or oscillate drill modes. They are only to be operated in the drill/ream mode.

 
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Brand NamePOWERPRO 5:1 ZIMMER/HUDSON REAMER ATTACHMENT
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
CONMED CORPORTATION
11311 concept boulevard
largo FL 33773
Manufacturer (Section G)
CONMED CORPORATION
11311 concept blvd.
largo FL 33773
Manufacturer Contact
denise curtis
11311 concept blvd.
largo, FL 33773
MDR Report Key6590160
MDR Text Key75932500
Report Number1017294-2017-00058
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPRO6047
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/07/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/09/2016
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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