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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES POWER TOOLS SAGITTAL SAW ATTACHMENT FOR PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.039
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/05/2016
Event Type  malfunction  
Manufacturer 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 hand surgical procedure, it was observed that the sagittal saw attachment device was working intermittently. There was a twenty minute delay to the surgical procedure. A spare device was available to complete the surgery successfully. There was patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. 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 the reported condition was not confirmed. A functional assessment was performed and the device functioned properly and passed all tests. Therefore, an assignable root cause was not determined. However, during evaluation, it was determined that there was corrosion on the bearings and internal components (non-failure). The assignable root cause was determined to be due to improper cleaning/care. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
 
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Brand NameSAGITTAL SAW ATTACHMENT FOR PEN DRIVE
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 Key6048341
MDR Text Key58244183
Report Number8030965-2016-15289
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.039
Device Lot Number1708134
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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