MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW, 5.0 LG, 40MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW, 5.0 LG, 40MM LGTH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
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 subtalar fusion procedure, the surgeon broke the threaded tip of ar-8750kt inside the patient¿s talus.No attempt was made to retrieve.The surgeon was attempting to change the position of the k wire and whilst drilling out on forward the tip was advancing whilst the shaft of the k wire was being withdrawn from the patient, hence a breakage is possible.In the same case the surgeon inserted a new ar-8750kt successfully.However, broke an ar-8750-40h inside the patient.The surgeon is very familiar with this system and all aspects of the insertion appeared to be completed correctly.Surgeon continued to insert screw even after considerable resistance was encountered; he didn¿t stop to remove the screw and re-drill or alter approach.The surgeon drilled with the correct 1.6 mm guide wire (ar-8750kt), measured with depth device (ar-8750-01), over drilled with 3.2 mm drill bit (ar-8750-09), hand powered profile drill (ar-8750-05), inserted screw by hand screw driver (ar-8750-03) and then finished with solid driver (ar-8750-06).The surgeon demanded the solid drill after twisting/ warping the end of the cannulated driver after excessive torsional force during first attempt to implant screw.Surgeon then completed the procedure using hardware from a different company.Procedure was completed successfully and no harm to patient.Additional information provided 03/06/2020: the broken fragment from the ar-8750-40f was left in the patient as well.The lot numbers of the screws are unable to be provided as they were not recorded at the facility and the screws were pulled from a tray.The patient has hard bone.No additional incision was needed.The screws will not be returned.

• Brand Name: COMPR FT SCRW, 5.0 LG, 40MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9805173
• Report Number: 1220246-2020-01750
• Device Sequence Number: 3003208
• Product Code: HWC
• UDI-Device Identifier: 00888867262867
• UDI-Public: 00888867262867
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: COMPR FT SCRW, 5.0 LG, 40MM LGTH
• Device Catalogue Number: AR-8750-40H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/09/2020
• 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