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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 02/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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
This is report 2 of 2 for the same event. It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the reduction drive unit device and the compact air drive device were not working together. It was not reported if there was a delay in the surgical procedure. It was reported that spare devices were available for use. There was patient involvement. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the device passed all operational specifications and no failure was identified. Therefore, the reported condition was not confirmed and an assignable root cause was not determined. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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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 Key7391417
MDR Text Key104274209
Report Number8030965-2018-52681
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
Report Date 03/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number511.701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

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