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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS STANDARD CONSOLE W/IRRIGATION INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS STANDARD CONSOLE W/IRRIGATION INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.000VET
Device Problems Loose or Intermittent Connection (1371); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/21/2017
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: (b)(4). The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that during a veterinary hemilaminectomy surgery, it was observed that the console device was working intermittently. According to the reporter, when the torque switch was wiggled, the device worked; however, as soon as it was let go, the device stopped. It was further reported that the left port was not working for months. The reporter stated that the device was not tested prior to surgery due to sterile equipment. It was reported that the issue occurred while in use on the patient or within the sterile field. There was approximately five to seven minutes delay to the surgical procedure to obtain a spare device. There was no human patient involvement as the device was used in a veterinary procedure. It was reported that there were reports of medical intervention and prolonged hospitalization. The reporter clarified that the medical intervention and prolonged hospitalization were secondary to the primary medical issue and not due to the delay in procedure. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
The actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the warranty seal was tampered with (the guarantee seal was damage). Therefore, the full pre-test could not be completed due to the tampering. It was further determined that the screws on the base of the console were missing and loose (countersunk screw was missing). It was determined that these issues were consistent with tampering. Therefore, the reported condition was not confirmed. Evidence suggested that there was unauthorized repair/modification (tampering) by the customer or third party. The assignable root cause was determined to be due to user misuse. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
 
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Brand NameSTANDARD CONSOLE W/IRRIGATION
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
hauptstrasse 24
waldenburg CH443 7
SZ CH4437
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
hauptstrasse 24
waldenburg CH443 7
SZ CH4437
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6472445
MDR Text Key72347792
Report Number8030965-2017-11686
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 03/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.000VET
Device Lot Number1742
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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