MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM BIOS-TAK SPEAR W/CIRCUM TEETH; ORTHOPEDIC MANUAL SURG INSTR

Model Number	3.0MM BIOS-TAK SPEAR W/CIRCUM TEETH
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the step drill for 3.0mm bio-suturetak® returned was stuck inside of the spear, for 2.8 mm fastak¿ ii, 3.0 mm suturetak®, trocar and 2.9 mm pushlock®, trocar tip with circumferential teeth.The anodized purple color had chipped around the edges of the handle.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage of the device.Manufacturing date 2014.
Event or Problem Description
On 02/19/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1250lt step drill got stuck in the drill guide when making the pre-hole.This occurred during a case where another ar-1250lt was used to complete the case.There was no harm to the patient.

• Brand Name: 3.0MM BIOS-TAK SPEAR W/CIRCUM TEETH
• 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: 19705705
• Report Number: 1220246-2024-06674
• Device Sequence Number: 11672853
• Product Code: LXH
• UDI-Device Identifier: 00888867024243
• UDI-Public: 00888867024243
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 07/09/2024

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 Model Number: 3.0MM BIOS-TAK SPEAR W/CIRCUM TEETH
• Device Catalogue Number: AR-1946
• Device Lot Number: 021420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown