MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI; PLATE, FIXATION, BONE

Model Number	LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
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 root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a fifth metacarpal fracture, when the surgeon was advancing the ar-18714-09, screw into the patient, once the screw was setting at 1mm before it was fully seated, the head broke.The screw remains in the patient but the head that broke was removed.The case was completed without further issue.

• Brand Name: LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11872257
• Report Number: 1220246-2021-03145
• Device Sequence Number: 17210820
• Product Code: HRS
• UDI-Device Identifier: 00888867303867
• UDI-Public: 00888867303867
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI
• Device Catalogue Number: AR-18714-09
• Device Lot Number: 2684402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1