MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,SS 2.7X 12MM; SCREW, FIXATION, BONE

Model Number LO-PRO LOCK SCRW,SS 2.7X 12MM

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

Patient Problems Fatigue (1849); Headache (1880); Tinnitus (2103); Dizziness (2194); Anxiety (2328); Reaction (2414); No Code Available (3191)

Event Date 11/22/2019

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 she had an original ankle procedure (b)(6) 2017.During the surgery six arthrex products were implanted.The patient developed allergic like reaction symptoms and recently had to undergo a second surgery on (b)(6) 2019 to explant the arthrex devices.Patient did not have an further details at the time of report but will provide soon.Additional information 1/8/2020: original procedure was on (b)(6) 2017 and was a left ankle orif.Following surgery the patient was in the hospital for three nights.She started having ringing in her ears and dizziness 3 months after surgery.This was followed by tiredness, migraines, and tmj on her right side.She also developed noticeably drier, flaky skin and more anxiety after about 6 months.She developed food intolerance to dairy and developed a thyroid nodule as well.Patient had a second surgery on (b)(6) 2019 to explant all of the original implant devices.The second surgery was performed by a different surgeon at a different facility.The following devices were reported to have been implanted (b)(6) 2017 and explanted (b)(6) 2019 (specific arthrex part numbers were not provided): ar-8926ss, knotless tightrope syndesmosis repair implant, lot 17016; ar-1688-cp, implant system, internal brace ligament augmentation repair with collagen coated fibertape, lot 10127689; ar-8943bl-04, locking distal fibula plate, ss, left, 4 hole, lot unknown; ar-8827l-10, qty 2, low profile locking screw, ss, 2.7 x 10mm; ar-8827l-12.Low profile locking screw, ss, 2.7 x 12mm; ar-8835-14, qty 3, low profile nonlocking cortical screw, ss, 3.5 x 14 mm.Patient reports she did not keep the implants because she did not want them.Patient also stated the tissue looked ok but that it does not rule out metallosis.

• Brand Name: LO-PRO LOCK SCRW,SS 2.7X 12MM
• Type of Device: SCREW, 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: 9631387
• MDR Text Key: 189910487
• Report Number: 1220246-2020-01609
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867047044
• UDI-Public: 00888867047044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143614
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LO-PRO LOCK SCRW,SS 2.7X 12MM
• Device Catalogue Number: AR-8827L-12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other