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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES POWER TOOLS QUICK COUPLING FOR K-WIRES INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.022VET
Device Problems Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2017
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 veterinary tibial plateau leveling osteotomy (tplo) surgery on a canine, it was discovered that the quick coupling device was making a grinding noise and a black residue came out of it. It was further reported that a small amount of the black residue fell into the patient but was flushed out vigorously. It was reported that there was a slight delay to the surgical procedure. The same device was used to complete the surgery successfully. There was no human patient involvement as the device was used in a veterinary procedure. 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

Additional narrative:the actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition was confirmed. A visual and functional assessment was performed on the device which found that the unit failed the smooth running check. During repair, it was observed that there was corrosion and unknown debris on the internal parts. It was determined that the bearing was damaged and had a rough rotation. It was further determined that the issues were consistent with improper cleaning. The assignable root cause was determined to be due to improper cleaning methods. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

 
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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 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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6903791
MDR Text Key87769098
Report Number8030965-2017-15172
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/29/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number532.022VET
Device LOT Number100832
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/25/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/24/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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