MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.4X11MM, CORTICAL,TI; PLATE, FIXATION, BONE

Model Number	LOW PROFILE SCREW, 1.4X11MM, CORTICAL,TI
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2022
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
On (b)(6) 2022, it was reported by a sales representative that an ar-18714-11 low profile screw had an issue.During a finger fracture procedure on (b)(6) 2022, when the surgeon was screwing the screw in, the screw reached the plate and the head of the screw broke off, fell out, was retrieved, and the shaft of the screw stayed inside the patient.The shaft was left inside the patient, a locking screw ar-18714v-01 (batch unknown) was added to provide additional fixation, and the case was completed successfully with no delay and no impact to the patient.The patient is fine to date.

• Brand Name: LOW PROFILE SCREW, 1.4X11MM, CORTICAL,TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14269490
• Report Number: 1220246-2022-04816
• Device Sequence Number: 12051685
• Product Code: HRS
• UDI-Device Identifier: 00888867303843
• UDI-Public: 00888867303843
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/02/2022

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, 1.4X11MM, CORTICAL,TI
• Device Catalogue Number: AR-18714-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown