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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC QUICK COUPLING FOR K-WIRES INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES PRODUCTS LLC QUICK COUPLING FOR K-WIRES INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.022
Device Problems Detachment Of Device Component (1104); Device Contamination with Chemical or Other Material (2944); Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2017
Event Type  Malfunction  
Manufacturer Narrative

The actual device was returned for evaluation. The quick coupling device was evaluated and the reported condition that black debris is coming out while in use, and sounds like something is catching on the pin when it is inserted into the device was confirmed. An assessment was performed and it was observed that a black substance was leaking from the device, the bearing was damaged with corrosion and rough rotation, the clamps were corroded, and the o-ring was worn. It was further determined that the device failed pretest for check for smooth running. The assignable root cause was determined to be due to improper cleaning and maintenance, 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 during a tibial plateau leveling osteotomy (tplo) surgical procedure on a canine it was observed that black debris was coming out of the quick coupling device and it sounded like something was catching on the pin when it was inserted into the device. It was reported there was no delay and the surgeon wiped off the device and kept using it to complete the surgery successfully. It was reported nothing fell into the patient. There was no human patient involvement as this was a veterinary procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was not reported, however it was reported that the event occurred in (b)(6) 2017. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.

 
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Brand NameQUICK COUPLING FOR K-WIRES
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES PRODUKTIONS GMBH
4500 riverside drive
palm beach gardens FL
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7083016
MDR Text Key93866739
Report Number8030965-2017-50304
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/09/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/05/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number532.022
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/07/2010
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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