• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problems Air Leak (1008); Difficult To Position (1467); Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
Reporter's phone number was not provided. This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the reported condition was confirmed. It was determined that the housing was damaged. The assignable root cause was determined to be due to wear from normal use and servicing. 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 from (b)(6) that during an unspecified surgical procedure, it was observed that the compact air drive device was not working, had an air leak and was difficult to attach to the attachment device. It was not reported if there were any delays in the surgical procedure or if a spare device was available for use. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The date of event was unknown. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer (Section G)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7424972
MDR Text Key105301805
Report Number8030965-2018-53036
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2018
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 Manufacturer03/27/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/09/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-