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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

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SYNTHES GMBH COMPACT AIR DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 511.701
Device Problems Noise, Audible (3273); Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Event Description
It was reported by (b)(6) that during service and evaluation, it was determined that the compact air drive device made an excessive noise and experienced an insufficient/low power. It was further determined that the device failed pretest for check for noticeable noise and check power with power test bench. It was noted in the service order that the device was not working. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2022. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate. Device evaluation: the actual device was returned for evaluation. During repair, an evaluation was performed and it was determined that the device making an excessive noise, identified during service and evaluation was confirmed. The assignable root cause was determined to be due to component failure from normal wear. Udi: (b)(4).
 
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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
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6107428552
MDR Report Key13869504
MDR Text Key288391245
Report Number8030965-2022-01830
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07611819085268
UDI-Public07611819085268
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
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 Manufacturer03/16/2022
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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