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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES POWER TOOLS CAD II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 511.701
Device Problems Partial Blockage (1065); Loss of Power (1475); Retraction Problem (1536); Incorrect Or Inadequate Test Results (2456); Failure of Device to Self-Test (2937); Power Problem (3010); Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 10/19/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). The 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 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 by (b)(6) that the compact air drive device reverse was beginning to lack power. During service and evaluation, it was noted that the device was over reverse, had early power loss, lacked power, lacked lubrication, and the trigger was blocked. It was also noted that the device failed pre-repair diagnostic tests for attachment coupling assessment, reverse locking mechanism function, function of soft mode switch, function of the trigger for fwd/rev mode, and the power with test bench. It was not reported if this event occurred during a surgical procedure. It was reported that there was no delay in a procedure due to the event. It was not reported if a spare device was available for use. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of this event was unknown. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
Device evaluation update: upon further evaluation, it was also determined that the device failed pre-repair diagnostic tests for assessment of the attachment coupling with attachment. This information does not change the assignable root cause of improper handling. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand NameCAD 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 Key6092199
MDR Text Key59838974
Report Number8030965-2016-15514
Device Sequence Number1
Product Code HWE
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 company representative,foreig
Reporter Occupation Service and Testing Personnel
Type of Report Initial,Followup
Report Date 10/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2016
Is this an Adverse Event Report? No
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 Manufacturer10/26/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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