MAUDE Adverse Event Report: ARTHREX INC. ANTEROLAT DIST TIB PLT, SS, RIGHT, 16H; PLATE, FIXATION, BONE

Catalog Number	AR-8963AR-16
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2018
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.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.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 patient underwent a surgery where an arthrex plate was implanted into the patient's ankle.On (b)(6) 2018, a revision surgery was performed to remove the plate.Follow-up investigation: the original surgery was performed on (b)(6) 2018.The rep is unsure how the plate broke and if the patient was experiencing any pain or discomfort prior to the revision.The same surgeon performed both, the original surgery and the revision.None of the explanted hardware is available for return.The following devices were also explanted: ar-8827l-30 / lot: 1530123, ar-8827l-32 / lot: 10015375, ar-8827l-34 / lot: 186497, ar-8835-20 / lot: 10143062, ar-8835-22 / lot: g52513, ar-8835-24 / lot: 10050103, ar-8835-24 / lot: w47426, ar-8835-26 / lot: w47430.

• Brand Name: ANTEROLAT DIST TIB PLT, SS, RIGHT, 16H
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7600185
• Report Number: 1220246-2018-00216
• Device Sequence Number: 18884458
• Product Code: HRS
• UDI-Device Identifier: 00888867223288
• UDI-Public: 00888867223288
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K151732
• 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): 06/14/2018

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 Catalogue Number: AR-8963AR-16
• Device Lot Number: 5261603
• 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: 05/23/2018
• Initial Report FDA Received Date: 06/14/2018
• 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