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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH QUICK COUPLING FOR K-WIRES INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES GMBH QUICK COUPLING FOR K-WIRES INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.022
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  
Event Description
It was reported from the (b)(6) that the quick coupling device was overheating and had a strange noise. 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 the 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 2021. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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. 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).
 
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Brand NameQUICK COUPLING FOR K-WIRES
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key12554208
MDR Text Key280759734
Report Number8030965-2021-08152
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07611819107199
UDI-Public07611819107199
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.022
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Is This a Reprocessed and Reused Single-Use Device? No

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