MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, TI, 4.5 X 55MM; PLATE, FIXATION, BONE

Model Number	LOW PROFILE SCREW, TI, 4.5 X 55MM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/25/2021
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 during an ankle fusion procedure, the head of a 4.5x55mm screw, ar-8545-55, broke off while the surgeon was inserting the screw into the compression hole of the mis fusion plate.The screw was able to be removed with broken screw instrumentation without any harm to the patient.Image attached.No additional information provided.Further information requested.Additional information provided on 3/30/21: the case was completed by inserting a 5.5mmx55mm, ar-8555-55, lot number unknown, and placed screw in the same drill hole with no other issues.The complaint device was discarded after the case and will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified and confirmed that the screw head had fractured off.However, without the return of the device, further investigation 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: LOW PROFILE SCREW, TI, 4.5 X 55MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11655670
• Report Number: 1220246-2021-02895
• Device Sequence Number: 11748887
• Product Code: HRS
• UDI-Device Identifier: 00888867124776
• UDI-Public: 00888867124776
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K141735
• 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): 09/01/2021

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, TI, 4.5 X 55MM
• Device Catalogue Number: AR-8545-55
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1