MAUDE Adverse Event Report: ARTHREX, INC. 3.0 X 12MM VAL SCREW, TI, STRL; BONE FIXATION SCREW/PLATE

Model Number	3.0 X 12MM VAL SCREW, TI, STRL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
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.The complaint is confirmed.Visual evaluation of the pictures of an alleged ar-8933v-12s attached to the complaint.It is inferred that there are damaged/nicks in the hexalobe, the threaded body of the screw, and geometry loss on the screw flute.The complaint is confirmed.One unpackaged ar-8933v-12s serial/batch number (b)(6) was received for investigation.Upon visual evaluation, it was found that the hexalobe shape head of the screw missed the geometry.The screw-threaded body showed nicks and damage in the anodize color.The cause remains undetermined.However, the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.
Event or Problem Description
On 2/24/2023, it was reported by an arthrex employee via email that an ar-8933v-12s low profile va locking screw thread would not lock.This was discovered during a procedure on (b)(6) 2023.Case was completed using a new product.Additional information received on 2/28/2023: this was discovered during a reconstructive fixation of the left fibula with hemorrhage.

• Brand Name: 3.0 X 12MM VAL SCREW, TI, STRL
• 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: 19520919
• Report Number: 1220246-2024-05621
• Device Sequence Number: 6424754
• Product Code: HWC
• UDI-Device Identifier: 00888867210257
• UDI-Public: 00888867210257
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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 Expiration Date: 10/31/2024
• Device Model Number: 3.0 X 12MM VAL SCREW, TI, STRL
• Device Catalogue Number: AR-8933V-12S
• Device Lot Number: 10433590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• 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
• Patient Sex: Unknown