MAUDE Adverse Event Report: ARTHREX INC. IMPLANT DELIVERY SYSTEM ,DISTAL BICEPS, BIO-COMPOSITE.; SCREW, FIXATION, BONE

Model Number	AR-2260BC
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/11/2017
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 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 there was a distal biceps revision surgery.The patient originally was notified that the implant was out of radius and backed itself out which led to the reason for the second surgery.Per the arthrex representative in the case, the surgeon took x-rays and opened up the surgical site, but was unable to locate the screw to be removed.The surgeon could not visualize the screw or feel it.The screw was not removed from the patient and the surgical site was closed.

• Brand Name: IMPLANT DELIVERY SYSTEM ,DISTAL BICEPS, BIO-COMPOSITE.
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6777669
• Report Number: 1220246-2017-00305
• Device Sequence Number: 10815541
• Product Code: HWC
• UDI-Device Identifier: 00888867204645
• UDI-Public: 00888867204645
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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 Model Number: AR-2260BC
• 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: 07/11/2017
• Initial Report FDA Received Date: 08/09/2017
• 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