MAUDE Adverse Event Report: ARTHREX, INC. LOW PROF SCRW,SS 4.0X 55MMCANN LNG THD; BONE FIXATION SCREW/PLATE

Model Number	LOW PROF SCRW,SS 4.0X 55MMCANN LNG THD
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-8840cl-55 low profile screw head was stripped, and the driver was unable to engage to implant it.This was discovered during a procedure on (b)(6) 2022.Additional information provided on 4/11/2022: the case was completed by using a new ar-8840cl-55.The procedure was a medial mal fracture.The lot number of the ar-8840cl-55 is unavailable.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.Upon visual inspection it was found that the head was stripped.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the screw.

• Brand Name: LOW PROF SCRW,SS 4.0X 55MMCANN LNG THD
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: jared engle ; 8009337001
• MDR Report Key: 19116182
• Report Number: 1220246-2024-02045
• Device Sequence Number: 12538348
• Product Code: HWC
• UDI-Device Identifier: 00888867048263
• UDI-Public: 00888867048263
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: LOW PROF SCRW,SS 4.0X 55MMCANN LNG THD
• Device Catalogue Number: AR-8840CL-55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown