MAUDE Adverse Event Report: ARTHREX, INC. BB-TAK, THREADED, STRL; ORTHOPEDIC MANUAL SURG INSTR

Model Number	BB-TAK, THREADED, STRL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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
It was reported during the lapidus arthrodesis with a plantar lapidus plate that the front part of the instrument, where the thread is located, broke off when screwing it in to fix the plate.The broken part could be removed without further damage.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-13226ts, bb-tak, batch number 5007155767, was received for investigation and upon visual inspection, it was observed that the shaft is broken off (see evaluation pictures 1 + 2).Functional testing was not performed due to the damage of the device.No fragments were returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied excessive mechanical forces during use and/or prying/leveraging the device during use.

• Brand Name: BB-TAK, THREADED, STRL
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 23295438
• Report Number: 1220246-2025-04594
• Device Sequence Number: 9917443
• Product Code: LXH
• UDI-Device Identifier: 00888867198609
• UDI-Public: (01)00888867198609(11)250201(17)300131(10)5007155767
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: BB-TAK, THREADED, STRL
• Device Catalogue Number: AR-13226TS
• Device Lot Number: 5007155767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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