MAUDE Adverse Event Report: ARTHREX, INC. LOCK DISTAL FIBULA PLT, SS RT, 4H; BONE FIXATION PLATE

Model Number	LOCK DISTAL FIBULA PLT, SS RT, 4H
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Failure to Advance (2524)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
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) 2025, it was reported by a sales representative via email that an ar-8943dr-04 locking distal fibula plate was not able to lock the screws into some of the 2.7 holes.An x-ray was taken of the plate where the screws were not locking in, and different lengths were tested.Upon reviewing the plates after the case, they found that the screws did not lock into five plates.This was discovered during an orif ankle procedure on (b)(6) 2025.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information received on 5/16/2025: the case was successfully completed without placing a screw in the designated hole of the plate.The procedure experienced a brief delay of three to five minutes, with anesthesia administered to account for the additional time.No components broke inside the patient.The patient is currently doing well and has experienced no negative effects during or after the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint device was not received for evaluation.Based on the available information, which may include the device (if returned), photographs, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure was user error.This included the following: the plate used is not a variable-angle plate.Therefore, if the screws are not perfectly aligned with the fixed-angle holes, they will not fully insert or lock into place, potentially damaging the plate's threads.Utilizing incompatible screws may compromise the overall performance and integrity of the implant.The complaint is confirmed based on the x-rays provided by the customer, which indicate the absence of a screw in one of the plate holes.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.The complaint device was not received for evaluation.Based on the available information, which may include the device (if returned), photographs, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure was user error.This included the following: the plate used is not a variable-angle plate.Therefore, if the screws are not perfectly aligned with the fixed-angle holes, they will not fully insert or lock into place, potentially damaging the plate's threads.Utilizing incompatible screws may compromise the overall performance and integrity of the implant.The complaint is confirmed based on the x-rays provided by the customer, which indicate the absence of a screw in one of the plate holes.
Event or Problem Description
Additional information: during the procedure, one ar-8943dr-04 plate from lot number 105642439 was attempted for use and remains successfully implanted in the patient.Several screws were attempted to be used with the plate and failed; however, the part number information is incomplete (ar-8827cl), and the lot numbers are unavailable due to prior record loss.The exact quantity and sizes of the failed screws could not be verified at this time.For the procedure, the bone was prepared using a 2.0 drill bit, and a locking tower was utilized for the 2.7 mm screws.The technique was not performed freehand.

• Brand Name: LOCK DISTAL FIBULA PLT, SS RT, 4H
• 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: 21971411
• Report Number: 1220246-2025-01924
• Device Sequence Number: 8492663
• Product Code: HRS
• UDI-Device Identifier: 00888867346871
• UDI-Public: (01)00888867346871(11)241003(10)105642439
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K123241
• 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,Followup,Followup
• Report Date (Section B): 09/02/2025

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: LOCK DISTAL FIBULA PLT, SS RT, 4H
• Device Catalogue Number: AR-8943DR-04
• Device Lot Number: 105642439
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: Not provided; 06/26/2025; 08/27/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/10/2025; 07/22/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown