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

Model Number	LO-PRO SCRW,TI,3.0MMX 20MMCORT, STRL
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/08/2022
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
It was reported that during a mtp fusion surgery the cortical screw head sheared off when inserting.No excessive force was used.As the screw contacted the plate, one turn of the screwdriver caused it to shear off.They had to leave the broken screw in the bone.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that only the head of the screw was returned for investigation.No problem was noted with the head of the screw.The cause of this remains undetermined.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 20MMCORT, 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: 14828825
• Report Number: 1220246-2022-05137
• Device Sequence Number: 4813598
• Product Code: HWC
• UDI-Device Identifier: 00888867210547
• UDI-Public: 00888867210547
• 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): 11/23/2022

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: 11/30/2024
• Device Model Number: LO-PRO SCRW,TI,3.0MMX 20MMCORT, STRL
• Device Catalogue Number: AR-8933-20S
• Device Lot Number: 10505168
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown