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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.224
Device Problems Partial Blockage (1065); Mechanical Problem (1384); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the mechanics swing fork was blocked and the sagittal saw attachment device was rough running.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported from germany that during service and evaluation, it was discovered that the sagittal saw attachment device was running rough and the mechanics swing fork was blocked.The event was not related to surgery.There was no patient involvement reported.There were no injuries, delays, or medical intervention associated with this event.The exact date of this 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 Name
SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS
Type of Device
INSTRUMENT, 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
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5217483
MDR Text Key31208934
Report Number3009450871-2015-14202
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 10/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05.001.224
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2015
Initial Date Manufacturer Received 11/04/2015
Initial Date FDA Received11/11/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2010
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
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