MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER COMPRESSION SCREW 4.0 X 26 MM; SCREW, FIXATION, BONE

Model Number	OF1024026S
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Company was informed of a removal of a protruding screw fragment from the bottom of the foot 4 months following a 1st metatarsal osteotomy.The protruding implant fragment (part of a screw) was successfully removed during a follow-up office visit.An image of the explanted implant part was shared but could not be examined as it was not provided.A product investigation was performed.Based on internal analysis of records and procedures, there is no indication of a design, manufacturing or process issue affecting device safety or effectiveness.Investigation revealed that in the original surgery the surgeon encountered difficulty to fully advance the implant and decided to remove and replace with a metal screw from a different manufacturer.Removal was done by drilling through the implant.Based on the investigation it was found that the event was caused by incomplete drilling though of the implant prior to the insertion of the metal screw at the time of implantation.The metal screw pushed the remaining implant fragment downwards and eventually out of the bone, into soft tissue.As the protruding implant fragment was removed and because the company cannot rule out the possible contribution of the device to the event, out of an abundance of caution, this event is being reported.Company continues to monitor these events as part of post market activities.The initial importer's report relating to this event is: #3014323288-2023-00004.
Event or Problem Description
Report of a removal of a protruding screw fragment from the bottom of the foot 4 months following a 1st metatarsal osteotomy.

• Brand Name: OSSIOFIBER COMPRESSION SCREW 4.0 X 26 MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• Manufacturer (Section G): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• Manufacturer Contact: taly lindner ; 8 hatochen st.; caesarea, 30798-61 ; IS 3079861
• MDR Report Key: 17875814
• Report Number: 3014554088-2023-00004
• Device Sequence Number: 11858647
• Product Code: HWC
• UDI-Device Identifier: 07290017630182
• UDI-Public: (01)07290017630182(17)241225(11)221226(10)OF03187
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K193660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/05/2023

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: 12/25/2024
• Device Model Number: OF1024026S
• Device Catalogue Number: OF1024026S
• Device Lot Number: OF03187
• 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: 09/12/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: METAL SCREW FROM A DIFFERENT MANUFACTURER; OSSIOFIBER TRIMMABLE FIXATION NAIL, CANNULATED 4MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male