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

Model Number	FIBULOCK IMPLANT SYSTEM, STERILE
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: FIBULOCK IMPLANT SYSTEM, STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8184263
• Report Number: 1220246-2018-00811
• Device Sequence Number: 13928839
• Product Code: HSB
• UDI-Device Identifier: 00888867303041
• UDI-Public: 00888867303041
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: FIBULOCK IMPLANT SYSTEM, STERILE
• Device Catalogue Number: AR-8973DS
• Device Lot Number: 10239936
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IN6300, TISSUE PROTECTOR, LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Weight: 68