MAUDE Adverse Event Report: INION OY INION FREEDOMSCREW; BONE SCREW

Model Number OSC-3545

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Foreign Body Reaction (1868)

Event Date 11/04/2018

Event Type  Injury  

Manufacturer Narrative

Please note: the electronic submission of this report was delayed due to persistent problems in establishing the webtrader production account.Final release documentation related to osc-3545 lot 1709003 was reviewed.All test results were according to specification.Inspection of the records showed that inion has not received any other feedback related to this lot.Based on the information from customer, edema was noticed in the surgical site one month after the operation.Three months after operation the affected part was edematous and infected.Based on the degradation tests, release of the degradation by products from inion freedomscrew during the first 6 months is minimal.Polymer (screw shaft) in the picture of the removed screw shaft was still clear / transparent, which indicates also that degradation of the screw has not started yet.This is in line with the test reports.Thus it is highly unlikely that adverse event would have been caused by degradation of the screw / polymer.

Event Description

Female patient with syndesmosis injury was operated by an open reduction and internal fixation (orif) using inion freedomscrew¿ on (b)(6) 2018.Edema was noticed one month after the operation on (b)(6) 2018.Three months after the operation the affected part was edematous and infected.Implant was removed on (b)(6) 2019.

• Brand Name: INION FREEDOMSCREW
• Type of Device: BONE 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: 9841271
• MDR Text Key: 186617864
• Report Number: 3003407235-2019-00001
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: M224OSC35459
• UDI-Public: M224OSC35459
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K123672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: OSC-3545
• Device Catalogue Number: OSC-3545
• Device Lot Number: 1709006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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: 20 YR