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

Catalog Number	AR-13280-45
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/29/2017
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 cc127086-line 210844-412, cc127086-line 210845-00413, cc127086-line 210835-00421 and cc127086-line 210838-00422, cc127086-line 210841-00424 and cc127086-line 210842-00425.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 and screw drilling went well.Good alignment of the plate.A crack was heard during the fixation of the cortical screws.A fissure in the bone was observed at post-op rx.The following devices were implanted at the time of procedure: ar-13110r-02 lot 1478185 (cc127086 line 209696), ar-13280-35 lot 1216262 (cc127086 line 210835), ar-13380-46 lot 10129095 (cc127086 line 210838), ar-13280-45 lot 10105613 (cc127086 line 210839), ar-13380-48 lot 10073031 (cc127086 line 210841), ar-13380-52 lot 10105330 (cc127086 line 210842), ar-13380-56 lot 10123181 (cc127086 line 210844) and ar-13280-70 lot 10073626 (cc127086 line 210845).

• Brand Name: SCREW, CANCELLOUS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7005822
• Report Number: 1220246-2017-00423
• Device Sequence Number: 13820451
• Product Code: HRS
• UDI-Device Identifier: 00888867010550
• UDI-Public: 00888867010550
• 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: 12/01/2021
• Device Catalogue Number: AR-13280-45
• Device Lot Number: 10105613
• 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-02 CONTURLK FEM OSTEO PLT RT LOT 1478185
• Outcome Attributed to Adverse Event: Other