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	09/18/2020
Type of Reportable Event	Serious Injury
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 a mtc fusion, upon insertion of the ar-8933-20, lo-profile screw, as the surgeon reached the plate the head of the screw broke off.The broken fragment was removed.The surgeon tried to remove the broken ar-8933-20 however, was unable to remove the screw body.The body of the screw was left in the patient.The surgeon drilled a second insertion site and the case was completed using a different ar-8933-20, lo-profile screw.Additional information obtained 09/21/2020: the second drill hole was not put into the same hole as the broken screw body, but was instead put in a new hole in the plate distal and proximal to the broken screw.The distal screw was an ar-8933-20 and proximal to the broken screw was an ar-8933-18.

• 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: 10634452
• Report Number: 1220246-2020-02220
• Device Sequence Number: 2727957
• Product Code: HWC
• UDI-Device Identifier: 00888867049567
• UDI-Public: 00888867049567
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.0MMX 20MMCORT
• Device Catalogue Number: AR-8933-20
• Device Lot Number: 10278031
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other