• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH COMPACT AIR DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/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
 

SYNTHES GMBH COMPACT AIR DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 511.701
Device Problems Noise, Audible (3273); Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2022
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The actual device was returned for evaluation. During evaluation it was determined that the initial reported condition of the device was blocked was not confirmed. Therefore, the assignable root cause was not determined. However, the malfunctions found during service and evaluation have been confirmed. The assignable root cause was determined to be due to component wear. Udi:(b)(4).
 
Event Description
It was reported from (b)(6) that during service and evaluation, it was determined that the compact air drive device had excessive noise, locking mechanism stiff/stuck, air leak and the moving parts did not move smoothly. It was further determined that the device failed pretest for check free movement, check for noticeable noise and air leak. It was noted in the service order that the device did not work. 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, an additional report 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 AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES PRODUKTIONS GMBH
hauptstrasse 24
waldenburg 4437
SZ 4437
Manufacturer Contact
kate karberg
eimattstrasse 3
oberdorf 4436
SZ   4436
3035526892
MDR Report Key14376025
MDR Text Key292372146
Report Number8030965-2022-03160
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10886982237644
UDI-Public10886982237644
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number511.701
Device Catalogue Number511.701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2022
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-