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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Burning Sensation (2146); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/18/2018

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 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: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: 10332236
• MDR Text Key: 200774378
• Report Number: 1220246-2020-01974
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867286801
• UDI-Public: 00888867286801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Device Catalogue Number: AR-8978-CP
• Device Lot Number: 10300153
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2019
• 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