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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC COMPACT AIR DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES PRODUCTS LLC COMPACT AIR DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 511.701
Device Problem Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2018
Event Type  malfunction  
Manufacturer Narrative
Reporter¿s phone number was not provided. 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 a radial neurolysis and cemented osteosynthesis surgical procedure, it was observed that the compact air drive did not work and could not be used for the procedure while in use with an air hose device. According to the report, an incision was made to remove a tumor on the femur before using the devices. It was reported that the patient was bleeding a lot from the incision but did not require blood transfusion. It was reported that the compact air drive device was dead and did not work at all when tested with other air hose devices while the air hose device was working great with other compact air drive devices. It was reported that there was a delay of half hour to one hour delay in the surgical procedure to get a replacement device. It was reported that the surgeon used a manual technique to complete the procedure successfully. There were no injuries, medical intervention or prolonged hospitalization. The patient's status post-op was stable. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
Adverse event box was not checked in error during initial medwatch submission.
 
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Brand NameCOMPACT AIR DRIVE II
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 Key7406194
MDR Text Key104670181
Report Number8030965-2018-52848
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 03/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number511.701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

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