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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number FIBULOCK IMPLANT SYSTEM, STERILE
Device Problem Temperature Problem (3022)
Patient Problem Burn, Thermal (2530)
Event Date 11/21/2018
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation. The cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported that as the surgeon was drilling the distal portion of the fibula with the 6. 2 reamer, the in6300 double sided tissue protector heated up while drilling, and the patient's tissue was burned. The rep reported that the bone quality was hard. Additional information received on 12/05/2018: the rep stated that the 6. 2 reamer being used was from ar-8973ds (lot: 10239936). The rep stated that the tissue was in contact with the in6300 double sided tissue protector, and as the surgeon was drilling with the 6. 2 reamer, the tissue protector heated up and burned the contacted skin. The rep reported that they are unaware of the size or appearance of the burn mark. The rep stated that they were made aware of the incident at the end of the procedure. The rep stated they do not have any information as to how the burn is being treated. It was confirmed that an arthrex handpiece was not being used. The rep confirmed that the patient did not have to stay overnight.
 
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Brand NameFIBULOCK IMPLANT SYSTEM, STERILE
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 Key8184263
MDR Text Key130999944
Report Number1220246-2018-00811
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 company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFIBULOCK IMPLANT SYSTEM, STERILE
Device Catalogue NumberAR-8973DS
Device Lot Number10239936
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/18/2018
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: 12/20/2018 Patient Sequence Number: 1
Treatment
IN6300, TISSUE PROTECTOR, LOT UNKNOWN.
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