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U.S. Department of Health and Human Services

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

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SYNTHES GMBH SAGITTAL SAW ATTACHMENT, LONG, FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.224
Device Problems Mechanical Jam (2983); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up 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 reported condition of device being frozen and not moving identified during service and evaluation was confirmed. The assignable root cause was determined to be traced to component failure due to wear. Udi: (b)(4).
 
Event Description
It was reported from (b)(6) that during service and evaluation, it was determined that the saw attachment device was frozen and would not move. It was further determined that the moving parts of the device did not move smoothly, the device did not function and the device had component damage. It was observed that the shaft was stiff and the housing was scratched. It was further determined that the device failed pretest for general condition, checking for mechanical free movement, checking general function in running mode and checking the oscillation frequency with frequency meter. It was noted in the service order that the device was making an abnormal noise. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2021. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameSAGITTAL SAW ATTACHMENT, LONG, 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
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6107428552
MDR Report Key13423558
MDR Text Key289978537
Report Number8030965-2022-00633
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07611819377929
UDI-Public07611819377929
Combination Product (y/n)N
Reporter Country CodeJA
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 12/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.224
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2022
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2013
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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