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

Catalog Number	AR-13380-54
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/05/2017
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 four submissions from the same event.The others are (b)(4).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 cause(s) of this event will be 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 the first screw ((b)(4)) caused a vertical fracture of the femur.A total of 7 screws were used; the fracture got longer with each screw.The case was finished and cerclage wire was used to hold the femur together.Femoral osteotomy.No additional hospitalization was needed.Follow-up investigation: it was reported that during a femoral osteotomy case the contourlock femoral osteo small right plate, ar-13110r-01 ((b)(4)) was used.When implanting the first cortical screw, ar-13380-54 ((b)(4)) in the most distal of the proximal holes the femur began to fracture.The fracture continued as the screws were implanted distal to proximal.The screws were implanted as follows: ar-13380-50 ((b)(4)), ar-13380-46 ((b)(4)) and ar-13380-36 ((b)(4)).The case was completed using another manufacture's 18 gauge wire (qty.2) to secure the fracture in cerclage technique.At this time the patient has not had a post op recheck.Patient is male, (b)(6).No additional hospitalization was needed.

• 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: 6725285
• Report Number: 1220246-2017-00270
• Device Sequence Number: 832142
• Product Code: HRS
• UDI-Device Identifier: 00888867011625
• UDI-Public: 00888867011625
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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: 01/01/2019
• Device Catalogue Number: AR-13380-54
• Device Lot Number: 1142990
• 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: 07/05/2017
• Initial Report FDA Received Date: 07/19/2017
• 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
• Patient Age: 35 YR