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

Model Number	OSH-3534
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported as the screw head cracked and although the fixation had been completed and the screw was left in place, to ensure proper placement of the screw after insertion the surgeon had to make another wound to the skin on the other side of the bone.This was the surgeon's first-time use of the inion compression screw which may have contributed to the insertion problems, especially when combined with the mini-invasive surgical technique.With mini invasive surgery, there is a risk that soft tissue will stick to the drill tap and partially damages the thread.Soft tissue can also adhere to the screw during the screw insertion phase, preventing the screw from advancing in the screw hole.These issues may cause the screw head cracking.In addition, in mini invasive surgery, it is difficult to see whether the screwdriver remains well in the bottom of the screw key hole all the time.If the screwdriver is not quite at the bottom of the key hole, the screw may crack at the end of the insertion.It has been observed that with inion compression screws, users have a learning curve.This product is biodegradable and contains as little material as possible, which makes its insertion very different from titanium screws.The titanium screw allows for lateral movement when inserting, but with this screw the screwdriver shall be kept in same direction with the screw all the time.The insertion is much more sensitive and controlled.It was checked that inion has not received any other complaint, and there are no nonconformities related to the osh-3534 lot 2210013.Lot history documents of osh-3534 lot 2210013 were reviewed.All dimensions and mechanical properties of the lot were within the specifications.Occurrence rate of compression screw breakage during insertion was also calculated and found to be very low.It was concluded that the main cause of the screw breakage has been the user's learning curve.
Event or Problem Description
During mini-invasive patellar fracture fixation, the surgeon experienced some problems in the insertion of the inion compression screw (inion compression screw 3.5 x 34 mm, headless, cannulated).Finally the screw head cracked while locking the screw with a little force.However, the fixation had been completed and the screw was left in place.To ensure proper placement of the screw, the surgeon had to make another wound to the skin on the other side of the bone to determine if the screw had penetrated the bone on the other side.No additional measures were taken and no re-operation was needed.

• Brand Name: INION COMPRESSON SCREW
• Common Device Name: 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: 19983174
• Report Number: 3003407235-2024-00004
• Device Sequence Number: 18201321
• Product Code: HWC
• UDI-Device Identifier: 06438408008412
• UDI-Public: 06438408008412
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K203105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/13/2024

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: 10/01/2025
• Device Model Number: OSH-3534
• Device Catalogue Number: OSH-3534
• Device Lot Number: 2210013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Unknown
• Patient Weight: 45 KG