MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW, 5.0 LG, 46MM LGTH; PLATE, FIXATION, BONE

Model Number COMPR FT SCRW, 5.0 LG, 46MM LGTH

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/03/2022

Event Type  malfunction  

Event Description

On 9/6/2022, it was reported by a sales representative via phone that an ar-8750-46h, an ar-8750-42h, and an ar-8750-38h had issues.During a fulkerson osteotomy procedure on (b)(6)2022, all three complaint devices were implanted, and the case was completed successfully with no impact to the patient.On (b)(6) 2022, the x-ray was showing that 2 of 3 screws were bending.On (b)(6) 2022, on the next x-ray, 2 of the 3 screws were broken inside the patient post-op.According to the x-ray and the sales representative, it was assumed that the ar-8750-46h and ar-8750-42h were broken.The broken screws were securely affixed inside the patient, and the surgeon was not planning a revision surgery and deemed it safe to leave the broken screws inside the patient, but just wanted to have the complaint reported.The patient is fine to date.On 09/14/2022, another sales representative called and provided via phone the following information: on (b)(6) 2022, a revision surgery was performed by the same surgeon to remove the broken ar-8750-46h and ar-8750-42h from the patient successfully.Both complaint devices were available for return.

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.

Manufacturer Narrative

Complaint confirmed.Upon visual inspection, it was noted that the device was broken.Measurements were unable to be taken due to the broken state of the device.The cause of this remains undetermined.

• Brand Name: COMPR FT SCRW, 5.0 LG, 46MM LGTH
• Type of Device: 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: 15484138
• MDR Text Key: 300581442
• Report Number: 1220246-2022-05519
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867262942
• UDI-Public: 00888867262942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COMPR FT SCRW, 5.0 LG, 46MM LGTH
• Device Catalogue Number: AR-8750-46H
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other