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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® LAG SCREW INSERTER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ARTHREX, INC. GALILEO® LAG SCREW INSERTER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number GALILEO® LAG SCREW INSERTER
Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 01/20/2022
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation. If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
On (b)(6) 2022 it was reported by a sales representative via sems that an 5030-000 multiple pieces of the lag screw inserter handle loosened and fell apart. This was discovered during use in a troch nail procedure on (b)(6) 2022.
 
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Brand NameGALILEO® LAG SCREW INSERTER
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key13472328
MDR Text Key287802658
Report Number1220246-2022-04435
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K202099
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGALILEO® LAG SCREW INSERTER
Device Catalogue Number5030-000
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Type of Device Usage Initial

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