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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 01/01/2021
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. 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 the chuck with key device was generating an unwanted sound and heat. It was not reported if the event occurred during a surgical procedure. It was not reported if there was a delay to a planned procedure. It was not reported if there was a spare device available for use. There was no patient involvement reported. 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.
 
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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
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6107428552
MDR Report Key12546645
MDR Text Key273774753
Report Number8030965-2021-08113
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07611819977860
UDI-Public07611819977860
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
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
Date Returned to Manufacturer09/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2016
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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