MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW, 5.0 LG, 42MM LGTH; PLATE, FIXATION, BONE

Model Number COMPR FT SCRW, 5.0 LG, 42MM LGTH

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

Patient Problem Unspecified Infection (1930)

Event Date 03/15/2022

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.If the device becomes available for evaluation, a follow-up report will be submitted.

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, 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-8750-50h 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.On 9/26/2022, the sales representative provided the following additional information on the phone: the post-op infection three weeks after surgery had occurred on the surgical site of the patient.Additional information has been requested on how the infection was treated.

• Brand Name: COMPR FT SCRW, 5.0 LG, 42MM 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: 15614884
• MDR Text Key: 301829857
• Report Number: 1220246-2022-05612
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867262928
• UDI-Public: 00888867262928
• 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
• Report Date: 10/17/2022

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 Operator: Health Professional
• Device Model Number: COMPR FT SCRW, 5.0 LG, 42MM LGTH
• Device Catalogue Number: AR-8750-42H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other