MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,ACL T-ROPE RT; SMOOTH FIXATION PIN

Model Number	IMPL DELIVERY SYS,ACL T-ROPE RT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was 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.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the tightrope tore while the surgeon pulled in the cruciate ligament.There was no harm for patient, operator or third party reported.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: complaint allegation is confirmed.One unpackaged ar-2323pslc-1 was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection under a microview noted no damage to the button.The sutures were broken/damaged.The most likely cause can be attributed to improper bone preparation; misaligned insertion; or prying/leveraging the device during use.

• Brand Name: IMPL DELIVERY SYS,ACL T-ROPE RT
• 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: emily shafer ; 8009337001
• MDR Report Key: 17908530
• Report Number: 1220246-2023-08131
• Device Sequence Number: 7543131
• Product Code: HTY
• UDI-Device Identifier: 00888867019607
• UDI-Public: 00888867019607
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100652
• 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): 11/12/2024

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: IMPL DELIVERY SYS,ACL T-ROPE RT
• Device Catalogue Number: AR-1588RTS
• Device Lot Number: 15062445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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