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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. FIB REMOVAL KIT (NON-STERILE, DISPOSABLE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ARTHREX, INC. FIB REMOVAL KIT (NON-STERILE, DISPOSABLE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number FIB REMOVAL KIT (NON-STERILE, DISPOSABLE
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2020
Event Type  Injury  
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.
 
Event Description
Original dos was (b)(6) 2018, a fibulock nail was used for an ankle fracture. Upon viewing x-rays, the surgeon thought that the nail had broken and so a second surgery was done (b)(6) 2020; he used the cs6910 removal screw from the st6900 fib removal kit. When attempting to remove the nail, the threads of the cs6910 broke off in the nail and then the screw broke. The surgeon determined that the original nail was not broken, so they did not proceed with the removal. The original nail is in the patient; it now contains debris threads from the cs6910. Unknown patient info.
 
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Brand NameFIB REMOVAL KIT (NON-STERILE, DISPOSABLE
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 Key10010810
MDR Text Key190334251
Report Number1220246-2020-01813
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160069
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFIB REMOVAL KIT (NON-STERILE, DISPOSABLE
Device Catalogue NumberST6900
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/29/2020 Patient Sequence Number: 1
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