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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC CHUCK WITH KEY F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

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DEPUY SYNTHES PRODUCTS LLC CHUCK WITH KEY F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED Back to Search Results
Catalog Number 530.730
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis.The actual device was returned for evaluation.The chuck with key device was evaluated and the reported condition that the device was loses all torque power when pressure was applied to bone was confirmed.An assessment was performed and it was observed that the drill chuck would not spin when pressure was added, and the device had wobbling / inconsistent rotation movement.It was further determined that the device failed pretest for free movement and untrue running.During repair it was observed that the transmission shaft was broken and there was an unknown debris on the bearings.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 that the chuck with key device lost all torque power when pressure was applied to the bone while in use with drill/reamer bit device.During in-house engineering evaluation, it was observed that the transmission shaft was broken on the device and there were unknown debris on the ball bearings.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.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 Name
CHUCK WITH KEY F/BPL
Type of Device
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ   4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 
SZ  
6107195000
MDR Report Key7629648
MDR Text Key112368735
Report Number8030965-2018-54516
Device Sequence Number1
Product Code GEY
UDI-Device Identifier7611819138667
UDI-Public(01)7611819138667(11)170615
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/30/2018
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 Number530.730
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2018
Initial Date Manufacturer Received 06/08/2018
Initial Date FDA Received06/22/2018
Date Device Manufactured06/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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