MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, PEEK; SCREW, FIXATION, BONE

Model Number	TENODESIS SCREW, PEEK
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Swelling (2091); Burning Sensation (2146); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)
Date of Event	12/18/2018
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 that the patient had a reaction to one of the devices implanted in a case on her right wrist in (b)(6) 2019 which was due to an injury roller skating about two years ago.Used during the case was ar-1530ps, ar-8978-cp and a k-wire, lot # 0919343245 (non-arthrex device).Two weeks after the case, the patient returned to the surgeon with swollen fingers and a burning sensation at the site.She is allergic to nickel; the surgeon was aware of this prior to the case but had thought the k-wire was titanium.When she returned.He rechecked the devices used and found that the k-wire did contain nickel; it was then removed from the patient.It was originally supposed to be in for eight weeks to immobilize the site and would have been removed after that.After it was removed, the patient's symptoms were reduced, but she still has mobility problems; she cannot close the index finger and the thumb hurts.Patient is a (b)(6) female.

• Brand Name: TENODESIS SCREW, PEEK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10332255
• Report Number: 1220246-2020-01975
• Device Sequence Number: 3749375
• Product Code: HWC
• UDI-Device Identifier: 00888867018662
• UDI-Public: 00888867018662
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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: 05/31/2024
• Device Model Number: TENODESIS SCREW, PEEK
• Device Catalogue Number: AR-1530PS
• Device Lot Number: 10326201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/28/2020
• 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