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

Model Number	FIB REMOVAL KIT (NON-STERILE, DISPOSABLE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2020
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 not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem 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.

• Brand Name: FIB REMOVAL KIT (NON-STERILE, DISPOSABLE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10010810
• Report Number: 1220246-2020-01813
• Device Sequence Number: 19575284
• Product Code: HSB
• UDI-Device Identifier: 00816988012436
• UDI-Public: 00816988012436
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/29/2020

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 Model Number: FIB REMOVAL KIT (NON-STERILE, DISPOSABLE
• Device Catalogue Number: ST6900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other