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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH AO REAMING ATTACHMENT FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES GMBH AO REAMING ATTACHMENT FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Model Number 05.001.210
Device Problems Noise, Audible (3273); Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2022
Event Type  malfunction  
Event Description
This is report 1 of 2 for the same event. It was reported from (b)(6) that the reaming attachment device and the chuck device were making noise while "application" and getting heated up. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in a surgical procedure, or if a spare device was available for use. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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 has been returned and is currently pending evaluation. Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly. Concomitant medical devices and therapy dates, chuck device, (b)(6) 2022. Udi: (b)(4).
 
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Brand NameAO REAMING ATTACHMENT FOR TRS
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
kate karberg
eimattstrasse 3
oberdorf 4436
SZ   4436
3035526892
MDR Report Key14166694
MDR Text Key289738393
Report Number8030965-2022-02587
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10886982129772
UDI-Public10886982129772
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,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number05.001.210
Device Catalogue Number05.001.210
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2012
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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