MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 38MM; PLATE, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3.5MMX 38MM
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Itching Sensation (1943); Distress (2329); Reaction (2414); Sleep Dysfunction (2517)
Date of Event	11/20/2017
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 therefore the complainant's event could not be verified.The root cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It was reported by a patient, through the arthrex website, that she had undergone a calcaneous repair procedure (b)(6) 2017.Less than two weeks post surgery patient's back started itching and this has since spread all over her body and patient reports this is causing her great stress and lack of sleep.At the time of initial report the patient did not have the arthrex product numbers for her implants.Patient has requested and will be provided with the material composition of her implants once the part numbers are provided to arthrex.Additional information obtained 4/3/2019: patient has provided the implant log from her surgery.The following are the patient's arthrex implant part numbers.Lot numbers were not provided on the implant log and are not available: calcaneous plate: ar-8954pr-xs (qty 1); 3.5mm locking screws: ar-8935l-28 (qty2), ar-8935l-22 (qty 1); 3.5mm non-locking screws:(qty 1 each) ar-8935-38, ar-8935-36, ar-8935-34, ar-8935-30, ar-8935-26, ar-8935-24.Material composition of the implanted devices is being provided to the patient.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 38MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8526644
• Report Number: 1220246-2019-01051
• Device Sequence Number: 1839715
• Product Code: HWC
• UDI-Device Identifier: 00888867050648
• UDI-Public: 00888867050648
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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: LO-PRO SCRW,TI,3.5MMX 38MM
• Device Catalogue Number: AR-8935-38
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other