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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  
Event Description
It was reported from (b)(6) that during service and evaluation, it was determined that the air reamer device had low power, was leaking air, the moving parts did not move smoothly, made excessive noise, the etching was illegible and the housing was worn. It was further determined that the device failed pretest for general condition, marking & labeling, check for mechanical free movement, check for noticeable noise, check power with power test bench and check for air leak. It was noted in the service order that the device does 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, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Device was used for treatment, not diagnosis. The device was returned for evaluation. During repair, an evaluation was performed and it was determined that the reported condition was confirmed. The assignable root cause was traced to component failure due to normal wear. Reporter number extension (b)(6). Udi:(b)(4).
 
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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 (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 Key13252344
MDR Text Key287179365
Report Number8030965-2022-00303
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,Followup
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
Is the Reporter a Health Professional? No
Date Manufacturer Received01/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2014
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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