MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, BIOCOMPOSITE; SCREW, FIXATION, BONE

Model Number	TENODESIS SCREW, BIOCOMPOSITE
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/27/2018
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 not returned for evaluation.The device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
During social safeguard cyber review a conversation was discovered which mentioned a hammertoe revision procedure.Upon further investigation it was discovered that a patient had undergone a revision surgery on (b)(6) 2018.During the revision procedure the surgeon explanted an ar-1540bc, bio-composite tenodesis screw.The explanted screw was fully intact, was removed and discarded at time of procedure.Once the screw was removed the surgeon filled the void with 1 cc of allosync putty and then placed staples.The reason for performing the revision and removing the screw is because the surgeon expressed concern about poor bone quality.Surgeon provided no further information to the sales rep with regard to the revision.The original procedure was performed by a different surgeon in a different city and further details from that procedure are not available.

• Brand Name: TENODESIS SCREW, BIOCOMPOSITE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8160323
• Report Number: 1220246-2018-00799
• Device Sequence Number: 11355565
• Product Code: HWC
• UDI-Device Identifier: 00888867018709
• UDI-Public: 00888867018709
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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 Model Number: TENODESIS SCREW, BIOCOMPOSITE
• Device Catalogue Number: AR-1540BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/13/2018
• 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