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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH AIR REAMER/DRILL II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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SYNTHES GMBH AIR REAMER/DRILL II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 511.606
Device Problems Noise, Audible (3273); Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Event Description
It was reported from (b)(6) that during service and evaluation, it was determined that the housing of the air reamer/drill device was worn, the device was making excessive noise, had insufficient/low power, component damage, an air leak, a worn bearing, and a worn seal.It was further determined that the device failed pretest for general condition, check for noticeable noise, check power with the power test bench, check starting behavior, and check for air leak.It was noted in the service order that the equipment 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.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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had insufficient/low power and was making excessive noise.Therefore, the reported condition that the device was not working was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi ¿ (b)(4).
 
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Brand Name
AIR REAMER/DRILL II
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6107428552
MDR Report Key12911065
MDR Text Key281532999
Report Number8030965-2021-09867
Device Sequence Number1
Product Code HWE
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,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number511.606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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