MAUDE Adverse Event Report: ARTHREX, INC. DRL PIN,ACL T-ROPE CLOSED EYELET,4MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRL PIN,ACL T-ROPE CLOSED EYELET,4MM
Medical Device Problem Codes	Dull, Blunt (2407); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
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 02/14/2025, it was reported by a sales representative via (b)(4) that an ar-1595tc acl tightrope, drill pin, closed eyelet was not able to drill.There was a small delay.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was received on 4/21/2025: during an acl reconstruction procedure on (b)(6) 2025, it was identified that the ar-1595tc drill pin had an inconsistent diameter along its length.This issue prevented the proper advancement of the cannulated reamer over the pin.The drill pin was not stuck, but its irregular dimensions interfered with the reaming process.No pieces of the instrument broke inside the patient, and no case delay was reported.The procedure was successfully completed by opening a new 4mm drill pin (ar-1595tc).The patient's bone quality was assessed as good, and no additional anesthesia was required.No adverse effects to the patient have been reported.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was not confirmed.One unpackaged ar-1595tc batch 15348148 was received for evaluation.A visual inspection found circular lines around laser mark number 3, erasing the laser mark.Gouges and marks were noted along the shaft.Evaluation of the spade tip revealed that the cutting edges were bent.The device's straightness was tested on surface plate #650, and it was noted that the device tilted, most likely due to being bent.The device diameter along the body and cutting tip was measured according to drawing c6191 at revision 6, and no out-of-tolerance/non-conformances were found.The device measurements are according to the drawing specifications.Functional testing was not performed due to not having the necessary parts to perform.The most likely cause of the reported failure is a user error, specifically bending the device with excessive force, which caused it not to perform as expected.

• Brand Name: DRL PIN,ACL T-ROPE CLOSED EYELET,4MM
• 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: 21468924
• Report Number: 1220246-2025-00675
• Device Sequence Number: 19706056
• Product Code: LXH
• UDI-Device Identifier: 00888867019904
• UDI-Public: (01)00888867019904(11)241114(17)291031(10)15348148
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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: DRL PIN,ACL T-ROPE CLOSED EYELET,4MM
• Device Catalogue Number: AR-1595TC
• Device Lot Number: 15348148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 04/21/2025; 06/25/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/20/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown