MAUDE Adverse Event Report: ARTHREX INC. LARGE PEC BUTTON; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	AR-2267
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/05/2018
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 for evaluation but part remains in the patient and cannot be returned therefore the complainant's event could not be verified.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.Device history record review revealed nothing relevant to this event.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 during a pec repair the large pec button, ar-2267 kept on breaking the fiber tape and would not slide through.The button remains in patient and was secured uni cortical.Due to the issue with the first pec button the surgeon had to drill another pilot hole and insert another large pec button to successfully complete the procedure without any further incident.

• Brand Name: LARGE PEC BUTTON
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7302195
• Report Number: 1220246-2018-00066
• Device Sequence Number: 2379346
• Product Code: MBI
• UDI-Device Identifier: 00888867026544
• UDI-Public: 00888867026544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• 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: 06/01/2019
• Device Catalogue Number: AR-2267
• Device Lot Number: 1190974
• 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