MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 20MMCORT; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3.0MMX 20MMCORT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2021
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.
Event or Problem Description
It was reported that the head of the screw broke off, leaving the remainder of the screw in the patient.This occurred during an mtp fusion case.The surgeon was attempting to remove the screw to use a shorter screw when the head broke off.Patient is male, 40s.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the head of the screw fractured.Without the return of the rest of the screw, further evaluation cannot be performed.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 20MMCORT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11724932
• Report Number: 1220246-2021-02951
• Device Sequence Number: 16914313
• Product Code: HWC
• UDI-Device Identifier: 00888867049567
• UDI-Public: 00888867049567
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• 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): 09/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.0MMX 20MMCORT
• Device Catalogue Number: AR-8933-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1