MAUDE Adverse Event Report: ARTHREX, INC. FDL IMPLANT SYSTEM, 4.75 MM; BONE FIXATION SCREW/PLATE

Model Number	FDL IMPLANT SYSTEM, 4.75 MM
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/16/2025, a sales representative reported via phone that during an fhl transfer procedure performed on (b)(6) 2025, an ar-1547bc-cp fdl implant system experienced a malfunction.Specifically, the 4.75 mm tenodesis screw broke in half at its top while being inserted halfway.All broken fragments were retrieved from the patient.To complete the procedure, they utilized the 5 mm reamer included in the kit to ream over the site and successfully implanted a 6.25 mm tenodesis screw without further issues.The case was delayed by 15 minutes, with no additional anesthesia required.No adverse effects were reported during or after the surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: FDL IMPLANT SYSTEM, 4.75 MM
• 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: 22720614
• Report Number: 1220246-2025-03262
• Device Sequence Number: 9132312
• Product Code: HWC
• UDI-Device Identifier: 00888867315150
• UDI-Public: (01)00888867315150(11)250123(17)281231(10)15376888
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• 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): 11/06/2025

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: FDL IMPLANT SYSTEM, 4.75 MM
• Device Catalogue Number: AR-1547BC-CP
• Device Lot Number: 15376888
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown