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

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS REPR
Health Effect - Clinical Code	Rash (2033)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11117374
• Report Number: 1220246-2021-02446
• Device Sequence Number: 19814176
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: 00888867026476
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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: 01/31/2025
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• Device Catalogue Number: AR-2260
• Device Lot Number: 10659977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/05/2021
• 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