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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH RADIOLUCENT-DRIVE SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES GMBH RADIOLUCENT-DRIVE SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 511.300
Device Problems Noise, Audible (3273); Complete Loss of Power (4015); Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
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. The reporter¿s phone number and complete facility address were not provided. The manufacturing site name is currently not available. Udi: the serial number was unknown; therefore, the device manufacture date is unknown, and the udi is incomplete. 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 during a fracture surgery of the shaft right femur, it was discovered that when drilling with the radiolucent drive device to insert the first locking screw, it took time to penetrate the cortex, partly because the patient's bone quality was good. It was reported that when the surgeon was about to drill the second locking screw, the radiolucent drive stopped working, making an abnormal sound. It was further reported that the surgeon managed to finish the procedure while cooling the heated connection part between the radiolucent drive and a driver bit using wet gauze. There was a thirty-minute delay to the surgical procedure. It was not reported if a spare device was available for use. It was reported that the surgery was completed successfully. There was 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 report will be submitted accordingly.
 
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Brand NameRADIOLUCENT-DRIVE
Type of DeviceSURGICAL, 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 Key13366818
MDR Text Key288285341
Report Number8030965-2022-00568
Device Sequence Number1
Product Code HWE
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
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number511.300
Was Device Available for Evaluation? No
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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