MAUDE Adverse Event Report: ARTHREX INC. BIO-COMPOSITE FULL THREADED INTERFERENCE SCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	AR-1370TC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
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.The device was requested and is expected but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.The most likely cause(s) for this type of event include not fully seating the driver in the screw or improper bone preparation.Per product directions for use (dfu-0111), it is important to completely seat the screwdriver to prevent potential screw fracture during insertion and to prepare the screw entrance insertion point using either the tap or dilator.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.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 reported that there was a thread failure preventing compression in the bone tunnel.The head of the screw broke inside the patient but the surgeon was able to remove this broken fragment.The rest of the partial screw is implanted in the tibia.Follow up investigation 26 september 2017: the surgeon confirmed that the tendon is securely fixed in tunnel only the screwdriver's footprint broke, about 3 mm, and was removed.The remaining 20 mm of the screw was left in the tibial tunnel as a partial implant and was reported to have a good hold.

• Brand Name: BIO-COMPOSITE FULL THREADED INTERFERENCE SCREW
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6934408
• Report Number: 1220246-2017-00368
• Device Sequence Number: 19055473
• Product Code: MAI
• UDI-Device Identifier: 00888867014725
• UDI-Public: 00888867014725
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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 Expiration Date: 02/01/2019
• Device Model Number: AR-1370TC
• Device Catalogue Number: AR-1370TC
• Device Lot Number: 10127796
• 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: 09/20/2017
• Initial Report FDA Received Date: 10/10/2017
• 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