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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION POWERPRO PRO7020 ATTACHMENT SAW, POWERED, AND ACCESSORIES

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CONMED CORPORATION POWERPRO PRO7020 ATTACHMENT SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO7020
Device Problems Break (1069); Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/05/2017
Event Type  Malfunction  
Manufacturer Narrative

As reported, the powerpro pro7020 attachment is expected to be returned for evaluation. However, as of this filing, the involved device has not yet been returned from the user facility. A supplemental and final report will be filed upon the completion of the product evaluation and the complaint investigation.

 
Event Description

The user facility reported that during use of a powerpro pro7020 attachment in a hip revision procedure, the device fell apart into 3 pieces while the surgeon was using the attachment to remove cement. As reported, the attachment was used for approximately 15 minutes into the case, when the incident occurred. The pieces that fell apart did not fall inside the patient and that the surgeon retrieved all the pieces. The procedure went on and completed with no alternate device used, no surgical delay and no patient injury. This report is filed on the basic of potential for patient injury with recurrence.

 
Manufacturer Narrative

The pro7020 powerpro attachment was returned to conmed for evaluation on 15-may-2017. Visual inspection of the attachment found the device was received in 3 pieces and functional testing therefore could not be performed. The unit was forwarded to the engineer for further examination. The returned parts were thoroughly evaluated and loctite was seen throughout the threads of the components, as expected. The report concluded that there was no evidence of insufficient loctite. In this instance, the root cause of the component detachment was unable to be determined. This device was manufactured on 08-nov-2016 with no service/repair history found. In this instance, the attachment has been in use approximately 6-months when this reported problem occurred. A 2-year review of the device history found 3 other similar complaints received and 2 were considered reportable events. To date, there have been no serious injury or death related to the reported problem of "component detached" or the use of this device. This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable. To reduce the risk of injury to the patient, the handpiece instruction manual provides the following precautions and warnings: handle all equipment carefully. If the handpiece or attachment is dropped or damaged in any way, return it immediately for service. Prior to each use, perform the following: · inspect all equipment for proper operation. Ensure all attachments and accessories are correctly and completely attached to the handpiece. Do not disassemble or lubricate the attachment.

 
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Brand NamePOWERPRO PRO7020 ATTACHMENT
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
CONMED CORPORATION
525 french road
utica NY 13502 5994
Manufacturer (Section G)
CONMED CORPORATION
11311 concept boulevard
largo FL 33773
Manufacturer Contact
n. kim grady
11311 concept boulevard
largo, FL 33773
7273995479
MDR Report Key6598737
MDR Text Key76402366
Report Number1017294-2017-00056
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 06/29/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2017
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? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/08/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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