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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3.0X130MM FIBULA NAIL, LEFT
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem Failure of Implant (1924)
Event Date 12/23/2020
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
It was reported that upon doing the initial 3. 0 reaming over the flexible guide pin, the tip of the guide pin broke off in the proximal fibula. This wasn't noticed on x-ray until the implant was fixated and final x-rays were taken. The pin was pushed further up the fibula during implantation. The doctor did not want to leave the broken pin in the bone and chose to remove the hardware. In order to do so, a proximal drill hole was made at the distal end of the pin to remove the pin. This took some time. Once removed, the current nail implant was inserted to be re-implanted. The proximal talons were attempted to deploy but bone debris or something was causing the nut to not fully push out the talons. This implant was removed and another fibulock implant was opened to complete the case. Two extra incisions were made in this case because of the hardware removal. One as mentioned in the proximal fibula and the second in the medial tibia to remove the syndesmosis button. Additional information provided 1/8/2021: procedure was a fibula orif with syndesmosis.
 
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Brand Name3.0X130MM FIBULA NAIL, LEFT
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 Key11186476
MDR Text Key227487436
Report Number1220246-2021-02482
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173656
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3.0X130MM FIBULA NAIL, LEFT
Device Catalogue NumberAR-8973L-30-130
Device Lot Number10422552
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/23/2019
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: 01/18/2021 Patient Sequence Number: 1
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