MAUDE Adverse Event Report: ARTHREX INC. QUICKFIX SCREW,TI,CANNULATED ST,CANC.,4.0X 48MM; PLATE, FIXATION, BONE

Catalog Number	AR-8740-48PTS
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.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.Lot number was not provided so device history record review cannot be performed.The contribution of the device to the event as reported could not be determined as the device was not returned for evaluation.Device history record review could not be performed as the lot number was unknown.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported via a facility fda medwatch (b)(4) that during an open reduction and internal fixation, left calcaneous procedure the 4.0mm cannulated screw broke off after insertion.The remaining screw fragment was noted within the sustentaculum tali.Fluoroscopy utilized to verify location to retain.Patient was a (b)(6) male, (b)(6).

• Brand Name: QUICKFIX SCREW,TI,CANNULATED ST,CANC.,4.0X 48MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6739501
• Report Number: 1220246-2017-00285
• Device Sequence Number: 1002960
• Product Code: HRS
• UDI-Device Identifier: 00888867046481
• UDI-Public: 00888867046481
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K103705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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 Catalogue Number: AR-8740-48PTS
• Device Lot Number: UNKNWON
• 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: 07/17/2017
• Initial Report FDA Received Date: 07/25/2017
• 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
• Patient Age: 23 YR
• Patient Weight: 81