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 Deformation (2976)

Patient Problem Unspecified Infection (1930)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

On 9/6/2022, it was reported by a sales representative via phone that an ar-8750-42h, an ar-8750-46h, and an ar-8750-50h 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.It was reported that the patient had a post-op infection three weeks after surgery.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, one of the screws had broken post-op inside the patient.On (b)(6) 2022, two of the screws were broken inside the patient post-op.According to the x-ray and the sales representative, it was assumed that the ar-8750-50h and ar-8750-46h 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.

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

Review of this complaint confirmed the event summary code selection and an investigation including a product history review was performed as required.The complaint device was not returned for investigation, however, picture(s) of the complaint device were provided and used for investigation.The investigation confirmed the reported condition.The probable cause of the event was not able to be determined.The investigation did not change the potential harm(s) identified.Complaint trending for this event will be performed per (b)(6).

• 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: 15484127
• MDR Text Key: 301015147
• Report Number: 1220246-2022-05517
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 12/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1