MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS, BC; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS, BC
Health Effect - Clinical Codes	Bacterial Infection (1735); No Code Available (3191)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was requested for evaluation but was not returned, therefore the complainant's event could not be verified.The device was reported to have been discarded by the facility.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; no issues were found with the sterilization of this lot.This device is supplied sterile.Result of cultures taken/type of organism(s) identified were confirmed as cutibacterium acas.Based on the information provided, a definitive cause for the post-operative infection could not be determined.The most likely cause for this type of event is a nosocomial source or patient non-compliance with post-op wound care directions.
Event or Problem Description
It was reported by the sales rep that the patient had to have three devices removed from shoulder due to infection.Original date of surgery was (b)(6) 2018; it was a rotator cuff repair with biceps tenodesis.The caller had no more information additional information obtained (b)(6) 2018: during the revision surgery all original implants were removed.No devices were implanted during the second surgery.Cultures were taken to confirm an infection.Culture results: cutibacteriun acas.Patient was prescribed antibiotics for the infections.No additional hospital stay was required.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7845540
• Report Number: 1220246-2018-00620
• Device Sequence Number: 16527869
• Product Code: MAI
• UDI-Device Identifier: 00888867204645
• UDI-Public: 00888867204645
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 03/31/2020
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Device Catalogue Number: AR-2260BC
• Device Lot Number: 10201610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/05/2018
• 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