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
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Discoloration (2074); Swelling (2091); No Code Available (3191)
Date of Event	04/18/2013
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 device remains in the patient.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 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8417382
• Report Number: 1220246-2019-00954
• Device Sequence Number: 13778928
• Product Code: HRS
• UDI-Device Identifier: 00888867052574
• UDI-Public: 00888867052574
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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 Model Number: LOCK DISTAL FIBULA PLT,SS RT,6H
• Device Catalogue Number: AR-8943BR-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/13/2019
• 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
• Patient Age: 50 YR