MAUDE Adverse Event Report: ARTHREX, INC. LOCK DISTAL FIBULA PLT,SS RT,6H; PLATE, FIXATION, BONE

Model Number LOCK DISTAL FIBULA PLT,SS RT,6H

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Discoloration (2074); Swelling (2091); No Code Available (3191)

Event Date 04/18/2013

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 device remains in the patient.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported by a patient that she had undergone ankle surgery on (b)(6) 2013 during which time arthrex devices were implanted.Patient may possibly be having an allergic reaction to the implant materials and was inquiring about the material composition.At time of initial report patient did not have the specific product numbers of her implants.Patient does not have an allergy to metal but does have allergies to at least one component of titanium, which is vanadium.Additional information obtained 2/18/19: the procedure on (b)(6) 2013 was to repair and ankle fracture.The patient's symptoms began several months after surgery.The area around the surgical site became swollen with skin discolorations as well as texture which continue several years post op.Patient has frequent feelings of stiffness and pressure in the area as well.Patient has been treated with mobic (non-steroidal anti-inflammatory drugs).Material composition of the implanted devices, which are comprised of stainless steel and meet astm standards, has been provided to the patient.The following devices were implanted during the (b)(6) 2013 procedure: ar-8943br-06, locking distal fibula plate, right 6 hole (qty 1).Ar-8835-12, low profile non-locking screw 12 mm - cortical (qty 5).Ar-8827l-12, low profile locking screw 12mm (qty 2).Ar-8827l-14, low profile locking screw 14mm (qty 1).Ar-8835-22, low profile non-locking screw 22mm- cortical (qty 1).

• Brand Name: LOCK DISTAL FIBULA PLT,SS RT,6H
• Type of Device: PLATE, 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: 8417382
• MDR Text Key: 138692372
• Report Number: 1220246-2019-00954
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867052574
• UDI-Public: 00888867052574
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LOCK DISTAL FIBULA PLT,SS RT,6H
• Device Catalogue Number: AR-8943BR-06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 50 YR