MAUDE Adverse Event Report: ARTHREX INC. IMPLANT SYSTEM BICEPS REPAIR; PLATE, FIXATION, BONE

Model Number	AR-2260
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, 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 was not returned 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.Lot number was not provided therefore device history record cannot be investigated.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 the patient had right shoulder bicortical proximal subpectoral tenodesis surgery on (b)(6) 2016.After surgery everything was on schedule with physical therapy and healing.In (b)(6) 2017 the patient started to experience sharp pain in his shoulder.He went to the doctor and had an x-ray performed.The titanium button had detached from the bone and was in the shoulder joint.Revision surgery done on (b)(6) 2017.Follow up investigation: in (b)(6) 2017 patient went to the doctor due to sharp pain in the shoulder.A mri was performed and a metallic foreign body was visible near the base of the coracoid process.A x-ray was also performed to confirm the findings of the mri.

• Brand Name: IMPLANT SYSTEM BICEPS REPAIR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6823447
• Report Number: 1220246-2017-00317
• Device Sequence Number: 10964518
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: 00888867026476
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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-2260
• Device Catalogue Number: AR-2260
• Device Lot Number: UNKNOWN
• 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: 08/11/2017
• Initial Report FDA Received Date: 08/28/2017
• 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