MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW,CORTICAL,3.5X13MM,DRP; PLATE, FIXATION, BONE

Model Number	LOW PROFILE SCREW,CORTICAL,3.5X13MM,DRP
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/24/2021
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported, that during a procedure, after insertion of ar-8735-13, screw, the surgeon notice a small fracture proximal and distal to the screw insertion site.Hole was drilled with 2.5 drill as per technique.Surgeon continued and felt no harm was done to patient and it will heal.No follow up with surgeon or the facility needed at this time.

• Brand Name: LOW PROFILE SCREW,CORTICAL,3.5X13MM,DRP
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11692676
• Report Number: 1220246-2021-02926
• Device Sequence Number: 16889171
• Product Code: HRS
• UDI-Device Identifier: 00888867288300
• UDI-Public: 00888867288300
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• 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): 04/20/2021

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 Model Number: LOW PROFILE SCREW,CORTICAL,3.5X13MM,DRP
• Device Catalogue Number: AR-8735-13
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/20/2021
• 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