MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 9MM, CORTICAL; PLATE, FIXATION, BONE

Model Number	LOW PROFILE SCREW, 1.6 X 9MM, CORTICAL
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2022
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 5/25/2022, it was reported by a sales representative via email that an ar-18716-09 cortical screw head broke off while being inserted into the ar-18714p-10 plate.The head was removed from inside the patient, however, the body of the screw remains implanted.This was discovered during a 2nd metacarpal base fracture procedure on (b)(6) 2022.
Additional Manufacturer Narrative
The complaint is not confirmed based on the customer provided photo, which displays the plate and screws.It cannot be determined based on the photo if the heads of the screws are present.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: LOW PROFILE SCREW, 1.6 X 9MM, CORTICAL
• 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: 14674434
• Report Number: 1220246-2022-05057
• Device Sequence Number: 4807833
• Product Code: HRS
• UDI-Device Identifier: 00888867313217
• UDI-Public: 00888867313217
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 10/13/2022

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, 1.6 X 9MM, CORTICAL
• Device Catalogue Number: AR-18716-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown