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

Catalog Number	AR-5028B-08
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/10/2017
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 device was received and an evaluation was conducted.The compalint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the screw was broken-off near the proximal threads.No other abnormalities were observed.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging while still loaded, improper bone preparation or flexing the joint during insertion.The bone tunnel, causing the implant to hit the edge of the prepared hole.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 originally reported that the screw broke during insertion.Follow-up investigation: half of the screw remained inside the patient.According to the surgeon the device is well fixed inside the patient.Also the surgeon reported that an extended skin incision was necessary.

• Brand Name: BIO-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: 7033769
• Report Number: 1220246-2017-00436
• Device Sequence Number: 944797
• Product Code: MAI
• UDI-Device Identifier: 00888867035287
• UDI-Public: 00888867035287
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062466
• 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): 11/15/2017

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: 12/01/2018
• Device Catalogue Number: AR-5028B-08
• Device Lot Number: 10103925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/15/2017
• 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