MAUDE Adverse Event Report: ARTHREX INC. SCREW, CORTICAL; PLATE, FIXATION, BONE

Catalog Number	AR-13380-38
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is one of seven submissions from the same single event.The others are cc126231-line 208645-00392, cc126231-line 210798-00393, cc126231-line 210801-00394, cc126231-line 210802-00395, cc126231-line 210803-00396 and cc126231-line 210805-00398.Device history record review revealed nothing relevant to this event.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 cause of the event could not be determined from the information available and without device evaluation.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient underwent a distal femoral osteotomy procedure where the following devices were implanted: cortical screw, ar-13380-34 (lot: 10140529, line 208645), ar-13110r-01 (lot: 10129525, line 210798), ar-13370-1 (lot: m16906p016, line 210799), ar-13370-2 (lot: m16914c015, line 210800), ar-13280-55 (lot: 10122391, line 210801), ar-13380-44 (lot: 10124044, line 210802) ar-13380-46, (lot: 10084866, line 210803), ar-13380-38 (lot: 10136981, line 210804), and, ar-13880-36 (lot: 10136979, line 210805) into the patient's femur.During the procedure, an ap x-ray was taken with no indications of any abnormalities.On (b)(6) 2017, the patient came in for a post-op check-up where a lateral x-ray was taken showing a fracture in the patient's femur.The patient has not experienced any pain or discomfort.The surgeon is going to keep the patient non-weight bearing for a few more weeks.Patient is a female.

• Brand Name: SCREW, CORTICAL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6975632
• Report Number: 1220246-2017-00397
• Device Sequence Number: 900074
• Product Code: HRS
• UDI-Device Identifier: 00888867011540
• UDI-Public: 00888867011540
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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 Expiration Date: 04/01/2022
• Device Catalogue Number: AR-13380-38
• Device Lot Number: 10136981
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/25/2017
• 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