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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH CUTTER FOR TI ELASTIC NAILS INSTRUMENT, CUTTING, ORTHOPEDIC

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SYNTHES GMBH CUTTER FOR TI ELASTIC NAILS INSTRUMENT, CUTTING, ORTHOPEDIC Back to Search Results
Catalog Number 359.217
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameCUTTER FOR TI ELASTIC NAILS
Type of DeviceINSTRUMENT, CUTTING, ORTHOPEDIC
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SALZBURG
vorgartenstrasse 206b
wien 1020
AU 1020
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key14948387
Report Number8030965-2022-04624
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number359.217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2022
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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