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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM GAUGE, DEPTH

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SYNTHES GMBH DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM GAUGE, DEPTH Back to Search Results
Catalog Number 03.019.017
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2022
Event Type  malfunction  
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Brand NameDEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM
Type of DeviceGAUGE, DEPTH
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES HAEGENDORF GMBH-CN
im bifang 6
haegendorf CO 4614
SZ 4614
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key15003001
Report Number8030965-2022-04804
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.019.017
Device Lot Number5L45926
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2019
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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