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

Model Number ACL-NNNN

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Foreign Body Reaction (1868)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

During a meeting with a chief surgeon the general use of bioabsorbable implants was discussed, and he mentioned that a small portion of the patients operated with the inion hexalon screw have some problems at the 2 year timepoint: transient local swelling/pain, and fluid accumulation.In all cases the performance objective i.E.Knee stability has been achieved.According to the received information, 5-10 patients (out of approximately 120 acl single bundle and double bundle reconstruction patients operated with free hamstring tendon grafts fixed with inion hexalon screws) experienced material-degradation related tissue reactions at the tibial implantation site approximately 2 years postoperatively.The tibial screws had been inserted flush with the outer cortex of tibia.In some cases (not all) surgical debridement and removal of implant remnants from the tibial implantation site was carried out.In one case the tibial bone tunnel was filled with bone graft after removing the screw remnants from the bone tunnel.However, all knees and the acl grafts were stable, there were no fixation failures, and re-reconstruction of the acl was not needed in any of the cases.Postoperative tissue reaction is a known risk which always exists when biodegradable implants are used.According to inion hexalon instructions for use: implantation of foreign materials can result in an inflammatory response or allergic reaction.Transient local fluid accumulation may occur in sterile circumstances.Tissue reactions are possible when the device degrades.However, the occurrence rate has been reported to be very low with polylactic acid based implants.This is in line with inion's experience, especially with the inion hexalon.Reporting has been delayed due to problems with webtrader.Problems with test account started in november 2019 and have been solved on daily basis with esb web helpdesk (ticket (b)(4)) until 13.2.2020 when we were able to send test submission.

Event Description

During a meeting with a chief surgeon the general use of bioabsorbable implants was discussed, and he mentioned that approx 120 patients operated with inion hexalon screws.5-10 patients have reported some problems ~2 years post operatively.They have had occasional pain, local swelling, bone edema and/or cyst.All these problems have occurred with a hexalon screw at tibia side.

• Brand Name: INION HEXALON
• Type of Device: INTERFERENCE SCREW
• Manufacturer (Section D): INION OY; lääkärinkatu 2; tampere, 33580 ; FI 33580
• Manufacturer (Section G): INION OY; lääkärinkatu 2; tampere, 33580 ; FI 33580
• Manufacturer Contact: kati marttinen ; lääkärinkatu 2; tampere, 33580 ; FI 33580
• MDR Report Key: 9828043
• MDR Text Key: 194775697
• Report Number: 3003407235-2019-00002
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K071464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACL-NNNN
• Device Catalogue Number: ACL-NNNN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR