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

Model Number	SCREW, CORTICAL
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the patient initially had a procedure on (b)(6) 2017.It was also reported that there were two screws which had broken post operatively which caused a delay in the bone consolidation.A second surgery was performed.The part number of the screws were ar-13380-xx however the exact size (xx) was not provided at time of report.The screws were reported to have been discarded.The type of procedure initially performed on (b)(6) 2017 and the date of the second surgery were not provided at time of initial report.Additional information has been requested.Update smer 06-nov-18: per arthrex (b)(4) the part number that were removed are ar-13380-40 & ar-13380-44.No further information received.
Additional Manufacturer Narrative
To update and correct information obtained regarding the follow-up investigation of the event.The original report event description listed the updated information as being received 6 nov 2018.The additional information was actually obtained 6 dec 2018.
Event or Problem Description
It was reported that the patient initially had a procedure on (b)(6) 2017.It was also reported that there were two screws which had broken post operatively which caused a delay in the bone consolidation.A second surgery was performed.The part number of the screws were ar-13380-xx however the exact size (xx) was not provided at time of report.The screws were reported to have been discarded.The type of procedure initially performed on (b)(6) 2017 and the date of the second surgery were not provided at time of initial report.Additional information has been requested.Update 06-dec-2018: per arthrex france the part number that were removed are ar-13380-40 & ar-13380-44.No further information received.

• 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: 8084131
• Report Number: 1220246-2018-00758
• Device Sequence Number: 16544015
• Product Code: HRS
• UDI-Device Identifier: 00888867011571
• UDI-Public: 00888867011571
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 10/31/2021
• Device Model Number: SCREW, CORTICAL
• Device Catalogue Number: AR-13380-44
• Device Lot Number: 10076350
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other