MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CORTICAL 4.5 X 40MM; BONE FIXATION PLATE

Model Number	SCREW, CORTICAL 4.5 X 40MM
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 07/24/2024, 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-13280-35 batch, unk, was received for investigation.The visual inspection revealed that the screw's threads were stripped, and the hex head geometry was damage.Additionally, the screw's threaded body exhibits nicks.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 40MM
• 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: 20011217
• Report Number: 1220246-2024-07221
• Device Sequence Number: 12563199
• Product Code: HRS
• UDI-Device Identifier: 00888867011557
• UDI-Public: 00888867011557
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• 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,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?: No
• Operator of Device: Health Professional
• Device Model Number: SCREW, CORTICAL 4.5 X 40MM
• Device Catalogue Number: AR-13380-40
• 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
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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