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

Catalog Number	AR-13380-50
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/04/2017
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 from the same single event.The others are cc127085-line 210847-414, cc127085-line 210849-00417, cc127085-line 210851-00418 and cc127085-line 210852-00419.Device history record review revealed nothing relevant to this event.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device remained in the patient.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.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 the dfo (distal femoral osteotomy) procedure went well , good alignement of the plate.All screws were drilled with ar-13319.A crack was heard during the fixation of the cortical screws.A fissure is visible in the post op x-ray.The following devices were implanted at the time of procedure: ar-13110r-01 lot 1142477 (cc127085 line 209692), ar-13280-70 lot 10076262 (cc127085 line 210847), ar-13380-42 lot 10081230 (cc127085 line 210849), ar-13380-46 lot 10084866 (cc127085 line 210851), ar-13380-56 lot 1142998 (cc127085 line 210852) and ar-13380-50 lot 10081367 (cc127085 line 210854).

• 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: 7005816
• Report Number: 1220246-2017-00420
• Device Sequence Number: 1599940
• Product Code: HRS
• UDI-Device Identifier: 00888867011601
• UDI-Public: 00888867011601
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

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: 11/01/2021
• Device Catalogue Number: AR-13380-50
• Device Lot Number: 10081367
• 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: 10/12/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-13110R-01 CONTURLK FEM OSTEO PLT RT LOT 1142477
• Outcome Attributed to Adverse Event: Other