MAUDE Adverse Event Report: ARTHREX INC. STANDARD PROCEDURE PACK; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	ST6100
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The device history record review revealed nothing relevant to the event.If the device is returned and additional information is obtained, a follow-up report will be submitted.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was discovered during monthly maude review that a facility had reported the following incident: "patient was undergoing surgery, on (b)(6) 2018, for displaced fracture of lateral malleolus of left fibula.While surgeon was using a reamer to ream the fibular nail the drill bit embedded into the bone and was unrecoverable after several attempts.Surgeon left it in the bone.Patient has recovered with no long term effects noted." maude report does not contain facility or reporter's name or contact information.No follow up possible.

• Brand Name: STANDARD PROCEDURE PACK
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7600211
• Report Number: 1220246-2018-00231
• Device Sequence Number: 1897678
• Product Code: HSB
• UDI-Device Identifier: 00816988011989
• UDI-Public: 00816988011989
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 10/01/2019
• Device Catalogue Number: ST6100
• Device Lot Number: A091017-05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/14/2018
• 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