MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 2.4 X 10MM, CORTEX; SCREW, FIXATION, BONE

Model Number LOW PROFILE SCREW, 2.4 X 10MM, CORTEX

Device Problems Positioning Failure (1158); Difficult to Advance (2920)

Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/03/2020

Event Type  Injury  

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 Description

It was reported constructive feedback was received from a surgeon regarding the 2.4 cortical screw (ar-8724) in the cfs set.The surgeon was treating a fracture across the midfoot and second metatarsal, and what they thought would be a 20 min case, turned into two hours and the surgeon having to bail to another system.The amount of axial load and force to get the 2.4 cortical screws to advance was significant, and the surgeon could not get the 2.4 cortical screws to advance without losing their reduction as a result of having to really lean into the screwdriver to advance the screw.The surgeon tried to make it work and wanted to stick with arthrex for their implant, but had to bail.Once the surgeon went to another manufacturer's system, the screws went in without any issue.The surgeon mentioned they noticed the screw tips have more of a snub nose and they are not sure if the self-tapping flutes where grabbing.It was confirmed that the correct drill bit was used.Additional information obtained 11/11/20: date of the surgery was (b)(6) 2020.The part numbers of the arthrex 2.4 screws attempted were: ar-8724-08, ar-8724-10 and ar-8724-12.The specific lot numbers of the screws are unknown as the tray housing the screws is owned by the facility and is constantly being restocked.Due to the length of time needed different anesthesia/inhalation gas was needed due to tourniquet pain proximal to the block.The screws attempted during the procedure were discarded at time of procedure.The distributor has obtained two ar-8724-08 unused screws that will be sent back for evaluation use.Additional information obtained 11/13/20: the following information was received regarding each screw part number involved: ar-8724-08 - (two screws total)two were successfully implanted and remained in the patient.Ar-8724-10 - (four screws total) two were successfully implanted and remained in the patient.Two were attempted but surgeon could not get the screws to advance without losing their reduction.Ar-8724-12 - (three screws total) all three were attempted but surgeon could not get the screws to advance without losing their reduction.None of the screws broke during insertion or attempted insertion.The facility only had two 2.4 cortical screws remaining in their tray.The two remaining were ar-8724-08 and those two are being returned to be used for evaluation and inspection.

• Brand Name: LOW PROFILE SCREW, 2.4 X 10MM, CORTEX
• Type of Device: 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: 10934397
• MDR Text Key: 219162510
• Report Number: 1220246-2020-02370
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867045071
• UDI-Public: 00888867045071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/02/2020

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
• Device Operator: Health Professional
• Device Model Number: LOW PROFILE SCREW, 2.4 X 10MM, CORTEX
• Device Catalogue Number: AR-8724-10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other