MAUDE Adverse Event Report: ARTHREX, INC. HYBRID VAL KREULOCK SCREW, TI, 3.0X14; PLATE, FIXATION, BONE

Model Number	HYBRID VAL KREULOCK SCREW, TI, 3.0X14
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 02/14/2022 it was reported by a sales representative via the phone that during an mtp fusion the surgeon inserted 4 screws from the sterilized caddy.After implanting the screws he notice that something was inside the threads of the screws.The sales rep stated it looked like the caddy was sterilized with the surgical labels inside.Caller was not in the case, did not have all the details.Additional information 02/15/2022: on 02/14/2022 it was reported by a sales representative via the email that during an mtp fusion on (b)(6) 2022, the surgeon implanted ar-9944s-0l compression plate (line #1), ar-8933hvcl-14 kreulock screw (line#2), ar-9933hy-16 3.0 hybrid screw (line#3), and ar-8933hvcl-18 kreulock screw ( line#4) after insertion an unknown debris was discovered on the shaft of the screws.The surgeon removed all three screws from the patient.No fragment or debris was left in the patient.The case was completed by using an alternative system adding 30 minutes to the procedure.
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
On 02/14/2022 it was reported by a sales representative via the phone that during an mtp fusion the surgeon inserted 4 screws from the sterilized caddy.After implanting the screws he notice that something was inside the threads of the screws.The sales rep stated it looked like the caddy was sterilized with the surgical labels inside.Caller was not in the case, did not have all the details.Additional information 02/15/2022: on 02/14/2022 it was reported by a sales representative via the email that during an mtp fusion on (b)(6) 2022, the surgeon implanted ar-9944s-0l compression plate (line #1), ar-8933hvcl-14 kreulock screw (line#2), ar-9933hy-16 3.0 hybrid screw (line#3), and ar-8933hvcl-18 kreulock screw ( line#4) after insertion an unknown debris was discovered on the shaft of the screws.The surgeon removed all three screws from the patient.No fragment or debris was left in the patient.The case was completed by using an alternative system adding 30 minutes to the procedure.

• Brand Name: HYBRID VAL KREULOCK SCREW, TI, 3.0X14
• Common Device Name: PLATE, 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: 13621634
• Report Number: 1220246-2022-04544
• Device Sequence Number: 5817878
• Product Code: HRS
• UDI-Device Identifier: 00888867324411
• UDI-Public: 00888867324411
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

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 Model Number: HYBRID VAL KREULOCK SCREW, TI, 3.0X14
• Device Catalogue Number: AR-8933HVCL-14
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown