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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH BURR ATCH, XL ANGLED FOR PEN DRIVE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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SYNTHES GMBH BURR ATCH, XL ANGLED FOR PEN DRIVE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 05.001.063
Medical Device Problem Codes Device-Device Incompatibility (2919); Excessive Heating (4030)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/01/2026
Type of Reportable Event Malfunction
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Brand Name
BURR ATCH, XL ANGLED FOR PEN DRIVE
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
elba bello
eimattstrasse 3
oberdorf 04436
SZ   04436
9083863534
MDR Report Key25748061
Report Number8030965-2026-06889
Device Sequence Number18678741
Product Code ERL
UDI-Device Identifier07611819927285
UDI-Public(01)07611819927285
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K043310
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,User Facility,Company Representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/08/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number05.001.063
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2026
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/02/2026
Initial Report FDA Received Date07/08/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured08/30/2023
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
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