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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS COMPACT AIR DRIVE II (CAD II) INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS COMPACT AIR DRIVE II (CAD II) INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 511.701
Device Problems Partial Blockage (1065); Corroded (1131); Material Discolored (1170); Retraction Problem (1536); Incorrect Or Inadequate Test Results (2456); Connection Problem (2900); Mechanical Jam (2983); Power Problem (3010); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 10/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. Reliability engineering evaluated the device and the reported condition was confirmed. The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported by (b)(6) that during service and evaluation, it was discovered that the motor power was too low on the compact air drive device. It was further determined that the trigger / slider was blocked, jammed and was moving heavy. It was observed that the device had lack of power, corroded and was rusted. It was further determined during the pre-repair diagnostics assessment that the device failed for check the attachment coupling, check attachment coupling with attachments, check reverse locking mechanism, check function of soft mode switch (safety system), check triggers for forward/reverse mode, check for untrue running, check for excessive noise, check the power with test bench and for check starting behavior. It was noted on the service order that the trigger was blocked. This event did not occur during surgery. There was no patient involvement. 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.
 
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Brand NameCOMPACT AIR DRIVE II (CAD II)
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 Key6095753
MDR Text Key59841090
Report Number8030965-2016-15530
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Service and Testing Personnel
Type of Report Initial
Report Date 10/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number511.701
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/1998
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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