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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH CHUCK WITH KEY/DRILL SPEED FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES GMBH CHUCK WITH KEY/DRILL SPEED FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.206
Device Problems Noise, Audible (3273); Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2022
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate. Additional narrative: initial reporter: please note that the reporter's name, phone number, and email address were not provided. 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 (b)(6) that after an unspecified surgical procedure it was observed that the chuck with key device was overheating and making a strange 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 not reported. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameCHUCK WITH KEY/DRILL SPEED 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
kate karberg
eimattstrasse 3
oberdorf 4436
SZ   4436
3035526892
MDR Report Key14287206
MDR Text Key290781134
Report Number8030965-2022-02936
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07611819977860
UDI-Public07611819977860
Combination Product (y/n)N
Reporter Country CodeHU
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
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.206
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2021
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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