MAUDE Adverse Event Report: INION OY INION INSTRUMENT; ORTHOPAEDIC SCREWDRIVER, REUSABLE

Model Number	1
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the instrument batch manufacturing records confirmed that the product batch is in specification.According to long-term pms data of inion cps and cps baby, a complication-to-operation ratio presented for the related risks below is: inion cps instrument fitting /implant picking problems is 0.02 % inion cps baby instrument fitting /implant picking problems is 0.03 % the investigation conclusions could not be established.Inion requested the initial reporter to send the screwdriver shafts used in the operation to inion, in order to inspect the devices in question.Additional information related to the infection was also requested in order to determine whether the infection was inion device-related.However, response was not received.The investigation will be continued in case inion receives the requested additional information.
Event or Problem Description
During a surgical procedure with inion cps and cps baby implants, there was a delay in the initial operation due to screw picking and insertion problems with the inion screwdriver.Additionally, the patient has suffered from postoperative infection and has got antibiotic treatment.A reoperation is planned to remove inion implants and replace them with titanium implants.

• Brand Name: INION INSTRUMENT
• Common Device Name: ORTHOPAEDIC SCREWDRIVER, REUSABLE
• 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: 24751932
• Report Number: 3003407235-2026-00008
• Device Sequence Number: 18731983
• Product Code: JEY
• UDI-Device Identifier: M224INS902910
• UDI-Public: M224INS902910
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K010351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: 1
• Device Catalogue Number: INS-9029
• Device Lot Number: 250060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INION CPS PLATE, REFERENCE UNKNOWN.; INION CPS: SCR-1224, 2.0 X 5 MM SCREW + EMGY.; INION CPS: SCR-1225, 2.0 X 7 MM SCREW + EMGY.; INION CPS: SCR-1284, 2.0 X 9 MM SCREW, 2 PACK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male