MAUDE Adverse Event Report: ARTHREX, INC. H/W INTERNALBRACE LGMNT AUGMNT REPR KIT; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Irritation (2076)
Date of Event	11/18/2020
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 through the arthrex website that the patient has been experiencing possible allergic reactions since having surgery using an arthrex internal brace for cmc.The patient has a two year old surgery scar that is on the shoulder/bicep area that is feverish.In addition the wrist, top and bottom, are also feverish.Patient reports a desmoid tumor in the same bicep.Doctor has prescribed clindamycin to try and combat the issue but the medication makes the patient sick to her stomach.Specific part number of implant(s) was not provided with initial report.Additional information obtained 12/14/2020: the patient's date of left hand surgery was (b)(6) 2020.Arthrex implant part number was ar-8978-cp implant system-hand/writs internal brace (lot 11759559).Five days post op when the patient was having her bandages changed out it was discovered that her left thumb and her bicep surgery scar were both feverish and red.Patient reports being in excruciating pain since surgery.Patient also has a desmoid tumor in her left bicep.She was originally concerned about implanting anything because the tumor had been shrinking without medical intervention.Her oncology team thought it would be ok to use the ar-8978-cp system.However since her tumor is very, very, rare it was a considered to be their best opinion.Her bicep scar had never been red previously and patient finds it odd that an anchor implanted in her thumb would cause an old surgical scar to become feverish along with the current surgical scar on her hand.Her surgeon is just treating with clindamycin.Patient took the medication for a few days and had to quit because it was making her sick.Patient reports having multiple allergies and states her body doesn't respond to things like most other people would.Patient states she does have a nickel allergy which is evident when she wears costume jewelry (makes her red and itchy wherever the jewelry touches).Patient states it is looking much better now.No cultures have been taken.

• Brand Name: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11116998
• Report Number: 1220246-2021-02442
• Device Sequence Number: 17124324
• Product Code: MBI
• UDI-Device Identifier: 00888867286801
• UDI-Public: 00888867286801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150648
• 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: 08/31/2025
• Device Model Number: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Device Catalogue Number: AR-8978-CP
• Device Lot Number: 11759559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• 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