MAUDE Adverse Event Report: INION OY INION HEXALON BIOABSORBABLE INTERFERENCE SCREW

Model Number	ACL-4103
Medical Device Problem Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
39-year-old male had a double bundle acl reconstruction surgery in spring 2019 where the graft fixations were performed with inion hexalon bioabsorbable interference screws.The knee recovered well after the operation but approximately 5 years after the acl reconstruction surgery a small cyst developed in front of the entrance of the tibial screw tunnel (pretibial cyst).In the mri image tibial tunnel cysts and a pretibial cyst measuring 15 x 13 x 16 mm were observed together with mild spongy bone edema surrounding the tibial tunnel cysts.Also, a connection between the pretibial cyst and the screw tunnel was seen.Approximately 5 years after the acl reconstruction surgery, the pretibial cyst was opened and emptied by a surgeon.
Additional Manufacturer Narrative
Approximately 5 years after acl reconstruction surgery, where the graft fixations were performed with inion hexalon interference screws, a small cyst developed in front of the entrance of the tibial screw tunnel (pretibial cyst).The patient experienced some pain symptoms due to the cyst and wanted it to be removed.An mri was taken prior to the opening and drainage of the cyst.According to the radiologist's report, the mri image showed a generally calm postoperative state following the acl reconstruction and mcl surgery, however, as a postoperative phenomenon, tibial tunnel cysts and a pretibial cyst measuring 15 x 13 x 16 mm was observed together with mild spongy bone edema surrounding the tibial tunnel cysts.Also, a connection between the pretibial cyst and the screw tunnel was seen and based on this the surgeon evaluated that the pretibial cyst liquid was degradation material of the bioabsorbable inion hexalon screw.No visible screw was left in the screw tunnel in mri anymore, only liquid.The pretibial cyst was opened and emptied (b)(6) 2024 by a surgeon and yellow clear liquid came out from inside the cyst.According to the surgeon the situation could have been handled also non-operatively and just wait the cyst to dissolve naturally.According to the surgeon, the pretibial cyst has now disappeared after operation but the process where the tibial tunnel cysts will turn into bone still takes time.Tunnel cysts sometimes occur after acl reconstruction operations which is related to the normal screw absorption process.Some of the tunnel cysts that occur have already turned into bone at the 5-year mark as stated by the operating surgeon but with this patient however, a tibial tunnel cyst was still observed at 5-years.Additionally with this patient there was still a narrow connection from the tibial tunnel to the surface of the bone and as a result, the content of the tibial tunnel cyst was able to drip to the bone surface due to the influence of gravity, creating an external cyst.It is likely that this incident is related to inion hexalon interference screw degradation.Sometimes transient local fluid accumulation may occur in sterile circumstances.Also, cyst formation has been observed at times when the device degrades.This information is also enclosed in the inion hexalon bioabsorbable interference screw instructions for use.

• Brand Name: INION HEXALON BIOABSORBABLE INTERFERENCE SCREW
• Common Device Name: INTERFERENCE SCREW
• Manufacturer (Section D): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer (Section G): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer Contact: kati marttinen ; lääkärinkatu 2; tampere, 33520 ; FI 33520
• MDR Report Key: 20394866
• Report Number: 3003407235-2024-00007
• Device Sequence Number: 20819368
• Product Code: HWC
• UDI-Device Identifier: 06438408002441
• UDI-Public: 06438408002441
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K021280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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 Expiration Date: 12/01/2021
• Device Model Number: ACL-4103
• Device Catalogue Number: ACL-4103
• Device Lot Number: 1812036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2018
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male