MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CORTICAL 4.5 X 48MM; BONE FIXATION PLATE

Model Number	SCREW, CORTICAL 4.5 X 48MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via phone that an ar-13110l-01 osteotomy plate all screws backed out and the plate collapsed.This occurred after use in a case and the patient requires a revision.The revision surgery was scheduled for (b)(6) 2024 and was completed successfully using a competitor osteotomy plate.No further injury to patient.
Additional Manufacturer Narrative
Complaint allegation confirmed.One unpackaged ar-13380-48 batch, unk, was received for investigation.The visual inspection indicated that the screw's threads were stripped, and the hex head was deformed.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.

• Brand Name: SCREW, CORTICAL 4.5 X 48MM
• Common Device Name: BONE FIXATION 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: 20010643
• Report Number: 1220246-2024-07217
• Device Sequence Number: 7257800
• Product Code: HRS
• UDI-Device Identifier: 00888867011595
• UDI-Public: 00888867011595
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCREW, CORTICAL 4.5 X 48MM
• Device Catalogue Number: AR-13380-48
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/12/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Unknown
• Patient Weight: 136 KG