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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS OSCILL-SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS OSCILL-SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 518.010
Device Problems Bent (1059); Break (1069); Device Operates Differently Than Expected (2913); Failure to Shut Off (2939)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. Reliability engineering evaluated the device and the reported condition was confirmed. The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse. If additional information should become available, a supplemental medwatch report will be submitted accordingly.

 
Event Description

It was reported by slovenia that the oscillating saw device works all the time, it does not stop. During service and evaluation, it was noted that the handle and lever were deformed and bent, and the valve lifter and handle were bent, the handpiece was out of lubrication, so the motor vanes were damaged. It was also noted that the device failed pre-repair diagnostic tests for operating assessment of the trigger/lever. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in a surgical procedure or if a spare device was available for use. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.

 
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Brand NameOSCILL-SAW
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
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6149052
MDR Text Key62187794
Report Number8030965-2016-15847
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeSI
PMA/PMN NumberK971544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 11/16/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/06/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number518.010
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/28/2016
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/26/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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