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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 12/09/2021
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. Additional narrative: the actual device was returned for evaluation. The device was evaluated and it was determined that the reported condition was not confirmed. Therefore, the assignable root cause was not determined. However, during evaluation, it was determined that the device was leaking air, had low power, made excessive noise, the moving parts did not move smoothly and the seal was worn. The assignable root cause was traced to component failure due to normal wear. Reporter number extension (b)(6). Udi: (b)(4).
 
Event Description
It was reported from (b)(6) that during service and evaluation, it was determined that the air reamer device was leaking air, had low power, made excessive noise, the moving parts did not move smoothly and the seal was worn. It was further determined that the device failed pretests for air leak, power with power test bench, check for noticeable noise and check for mechanical free movement. 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. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameAIR REAMER/DRILL II
Type of DeviceINSTRUMENT, 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 Key13255496
MDR Text Key289746188
Report Number8030965-2022-00326
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
Type of Report Initial
Report Date 01/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number511.606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2014
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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