MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100; SMOOTH FIXATION PIN

Model Number	IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/08/2024 it was reported by a sales representative via phone that an ar-4152ds trim-it drill pins clear pin has a bubble that widened the shaft and was unable to fit through the drill sleeve.This occurred during use in a case with no patient effect.Case completed using a drill pin that was long enough to seat.Delay in case 30 minutes.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device has not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint allegation was confirmed.Three sealed packaged ar-4152ds serial/batch number (b)(6) were received for evaluation.The device that failed was not received for evaluation.Upon visual inspection of the returned devices, no defects were observed.There were no bubbles or defects found on the poly (l-lactide) of the trimit drillpin 2.0 mm, metal tip.However, upon reviewing the customer's photographs, a defect resembling a small bubble was noted on the shaft of the poly (l-lactide) material.The most likely cause of the reported failure is supplier manufacturing issue.
Additional Manufacturer Narrative
The complaint allegation was confirmed.Three sealed packaged ar-4152ds serial/batch number (b)(6) were received for evaluation.The device that failed was not received for evaluation.Upon visual inspection of the returned devices, no defects were observed.There were no bubbles or defects found on the poly (l-lactide) of the trimit drillpin 2.0 mm, metal tip.However, upon reviewing the customer's photographs, a defect resembling a small bubble was noted on the shaft of the poly (l-lactide) material.The reported failure is a supplier manufacturing issue.(b)(4) was opened to address this issue.
Additional Manufacturer Narrative
The complaint allegation was confirmed.Three sealed packaged ar-4152ds with serial/batch number (b)(6) were received for evaluation.The device that allegedly failed was not received for evaluation.Upon visual inspection of the returned devices, no defects were observed.No bubbles or defects were found on the poly (l-lactide) of the trimit drillpin 2.0 mm, metal tip.However, upon reviewing the customer¿s photographs, a small bubble was noted on the shaft of the poly (l-lactide) material, and the tip of the device was deformed.The method of bone preparation employed during the procedure and the bone quality encountered were not provided.The reported failure is due to a use/technique error.When the implant resists entering the bone, the wire driver spins at significant speed without any advancement, which could cause a bubble to form due to the amount of torque.The predrill in this system should always be used to prepare the canal.Additionally, very hard bone could be a factor in the failure.

• Brand Name: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Common Device Name: SMOOTH FIXATION PIN
• 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: 19466618
• Report Number: 1220246-2024-04902
• Device Sequence Number: 18016880
• Product Code: HTY
• UDI-Device Identifier: 00888867032811
• UDI-Public: 00888867032811
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K050259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/29/2025

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: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Device Catalogue Number: AR-4152DS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 09/17/2024; 09/27/2024; 01/03/2025
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 09/24/2024; 10/09/2024; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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