MAUDE Adverse Event Report: ARTHREX INC. BIO-INTERFENCE SCREW CAN-DELTA TAPER 9X35MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-5035TB-09
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/19/2017
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.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.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 post-op, the ar-5035tb-09 screw was loose and misaligned in the tibia.The loose screw was subcutaneous palpable.The patient also complained about discomfort.The surgeon decided on a revision surgery.The initial surgery on (b)(6) 2015 was an acl on the left knee joint.

• Brand Name: BIO-INTERFENCE SCREW CAN-DELTA TAPER 9X35MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7302198
• Report Number: 1220246-2018-00064
• Device Sequence Number: 2248650
• Product Code: MAI
• UDI-Device Identifier: 00888867035461
• UDI-Public: 00888867035461
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

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: 01/01/2017
• Device Catalogue Number: AR-5035TB-09
• Device Lot Number: 1217228
• 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: 02/05/2018
• Initial Report FDA Received Date: 02/28/2018
• 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