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

Catalog Number	AR-13380-46
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
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 five submissions for the same event.The others are (b)(4).Device history record review revealed nothing relevant to this event.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The cause of the event is undetermined.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 during a distal femoral osteotomy procedure, as the surgeon inserted the last screw on the contourlock osteo plate (ar-13110l-02, lot: 10156990), a proximal vertical fracture occurred in the patient's left femur.The surgeon wrapped two stryker cables around the femur to secure the fracture and the case was completed with no further complications.There have been no reports of complications since the surgery.It is unknown which screw was being inserted at the time the fracture occurred.The following screws were implanted along with the plate: ar-13280-70, lot: 10111026 / (b)(4).Ar-13380-46, lot: 10084866 / (b)(4).Ar-13380-46, lot: 10137003 / (b)(4).Ar-13380-44, lot: 10140533 / (b)(4).Ar-13380-44, lot: 10130957 / (b)(4).

• 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: 7120776
• Report Number: 1220246-2017-00478
• Device Sequence Number: 1080104
• Product Code: HRS
• UDI-Device Identifier: 00888867011588
• UDI-Public: 00888867011588
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

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: 12/01/2021
• Device Catalogue Number: AR-13380-46
• Device Lot Number: 10084866
• 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: 11/30/2017
• Initial Report FDA Received Date: 12/15/2017
• 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