MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS REPR; PLATE, FIXATION, BONE

Model Number IMPL DELIVERY SYS,DISTAL BICEPS REPR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported by the patient that he had a distal bicep repair done in late (b)(6) 2020 and has had a body rash since that time.Additional information obtained 12/18/2020: the patient's implant surgery was(b)(6) 2020.His symptoms first appeared (b)(6) 2020.Symptoms has been a rash covering his body.To date the symptoms have been treated with creams, antihistamines, and phototherapy.No cultures have been taken to date.Patient also states that as of this date his surgeon, er doctor, allergist and one dermatologist all agree that the rash has nothing to do with his implant.His last dermatologist also thinks that it is not being caused by the implant.That dermatologist suggested researching the components to see if patient is possibly allergic to anything in the implant.The dermatologist is convinced also that whatever the patient is experiencing has nothing to do with the implants.Material composition has been provided to the patient.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 11117374
• MDR Text Key: 225110109
• Report Number: 1220246-2021-02446
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: 00888867026476
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• Device Catalogue Number: AR-2260
• Device Lot Number: 10659977
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other