MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
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
It was reported that during a tarsometatarsal fusion surgery using the 5 hole 3mm straight plate the surgeon implanted a 3x18mm cortical screw.When tightening the screw the head sheered off with a clean break.The surgeon was able to continue and complete the surgery but the screw shaft was left in place, not prominently, but he was unable to remove it.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint is confirmed.(2) photographs of an ar-8933-18s cortical screw head were provided as evidence for evaluation.Visual inspection identified the object as a screw head detached from the screw shaft.The screw shaft was not present in the photographs.Without additional information, the cause of the breakage remains undetermined.A probable cause could be attributed to excessive mechanical forces during tightening, likely via over-torqueing the screw, or insertion of the screw into the screw hole at an angle other than normal to the plate surface.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL
• Common Device Name: SCREW, 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: 13759028
• Report Number: 1220246-2022-04610
• Device Sequence Number: 5270605
• Product Code: HWC
• UDI-Device Identifier: 00888867210530
• UDI-Public: 00888867210530
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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 Expiration Date: 05/31/2025
• Device Model Number: LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL
• Device Catalogue Number: AR-8933-18S
• Device Lot Number: 11166123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 08/16/2022
• Date Device Manufactured: 06/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown