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 Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex employee via email that for an ar-1595tc, drill pin, acl tightrope®, closed eyelet, 4 mm, the spade tip broke off when drilling through femoral condyle.This was detected during use in an acl revision procedure on (b)(6) 2025.The procedure was completed successfully as the broken tip was retrieved and a 2.4 drill pin was used to correct it.On (b)(6) 2025 - the complaint initiator replied that the purpose of the revision procedure was because the patient's initial patellar tendon acl reconstruction had failed when the patient returned to sport too early without completing an adequate return to play/ rehabilitation program.On (b)(6) 2025 - the complaint initiator received updates that although initially it was believed that all of the broken material was removed from the patient during the surgery.Subsequently on a precautionary x-ray there was still metal left in the patient.This patient had a subsequent follow up surgery yesterday for the foreign material to be removed which was part of the spadetip drill pin.No reported ¿patient harm¿ apart from having to have a follow-up 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: b5, g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an ar-1595tc, with batch number 15427066, revealed that the device's tip was damaged.Therefore, arthrex was able to conclude a most likely cause.The most likely cause can be attributed to misaligned insertion or prying/leveraging the device during insertion.
Event or Problem Description
3rd october 2025 - there was hardware in knee prior to the procedure as it was a revision situation ¿ btb tightrope button sitting on lateral femoral condyle cortex and a distal screw in the tibia.Both not in direct influence of the spadetip drill that broke.It was also on the first attempt at drilling through the femur.

• 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: 22842751
• Report Number: 1220246-2025-03537
• Device Sequence Number: 4927009
• Product Code: LXH
• UDI-Device Identifier: 00888867019904
• UDI-Public: (01)00888867019904(11)250428(17)300331(10)15427066
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 10/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DRL PIN,ACL T-ROPE CLOSED EYELET,4MM
• Device Catalogue Number: AR-1595TC
• Device Lot Number: 15427066
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown