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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT, LONG, FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED

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DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT, LONG, FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED Back to Search Results
Catalog Number 05.001.224
Device Problems Overheating of Device (1437); Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). The manufacturing location was unknown. Device manufacture date is unknown. The device serial or lot number is unknown. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported from (b)(6) that during a total knee replacement surgical procedure, it was observed that the saw attachment device when started, worked properly but immediately began to overheat and stopped working. It was reported that the device had to be cooled throughout the surgery in order to return to work for a few seconds. It was reported that the surgery was delayed by 40 minutes trying to cool the saw adapter so that it worked each time it overheated. It was reported that a spare device was not available for use. There was patient involvement. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameSAGITTAL SAW ATTACHMENT, LONG, FOR TRS
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7322016
MDR Text Key102103621
Report Number8030965-2018-51735
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
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 01/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.224
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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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