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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, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT, LONG, FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.224
Device Problems Device Inoperable (1663); Output below Specifications (3004)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 an unspecified surgical procedure, it was observed that the sagittal saw attachment device lacked power. It was unknown if there were any delays to the surgical procedure. A spare device was used to complete the procedure. 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.
 
Manufacturer Narrative
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the device bearings did not function. The device failed pretest for check the saw performance, check the oscillation frequency min. 9900 to 12100 osc/min, check of free movement and check the saw blade tool coupling, marking and labeling. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to improper maintenance which is user error/misuse/abuse. 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, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key7393382
MDR Text Key104428904
Report Number8030965-2018-52724
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

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