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U.S. Department of Health and Human Services

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

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SYNTHES GMBH SAGITTAL SAW ATTACHMENT FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Model Number 05.001.223
Device Problems Noise, Audible (3273); Complete Loss of Power (4015); Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. Udi: (b)(4).
 
Event Description
It was reported from the (b)(6) that the saw attachment device had overheating, strange noise and no performance. 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. The exact date of this event was unknown but was noted to have occurred in 2022. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameSAGITTAL SAW 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 Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6107428552
MDR Report Key13757301
MDR Text Key287582173
Report Number8030965-2022-01577
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10886982130013
UDI-Public10886982130013
Combination Product (y/n)N
Reporter Country CodeHU
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number05.001.223
Device Catalogue Number05.001.223
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2020
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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