MAUDE Adverse Event Report: OSTEOCENTRIC TECHNOLOGIES, INC. 8.0 X 165MM CANN SCREW FASTENER FULL THD

Model Number	380-5165-001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.A review of the manufacturing records for the finished device found no nonconformances or manufacturing irregularities that could have contributed to this issue.
Event or Problem Description
Dr.(b)(6) performed a revision surgery at (b)(6) hospital to address a broken 8.0mm fully threaded pelvic screw manufactured by a company other than osteocentric.The surgical team began by removing the damaged screw.They attempted to place an osteocentric 8.0 x 165mm can screw fastener full thd, using the same path.However, they were unable to fully seat the fastener.The fastener became bent, and the k-wire snapped during removal.The system includes a tap for use in dense bone, however it was not used in this instance.The second attempt with another osteocentric 8.0 x 165mm cann screw fastener full thd they tried placing the fastener, and this time drilled and tapped the bone to reduce resistance.Despite that, there was still enough resistance near the end that the fastener head snapped off when attempting to seat it at the iliac crest.After removing the broken fastener, the surgeon re-drilled and tapped again, and was then able to successfully place an osteocentric 170mm, 8.0mm cannulated fastener.There was no harm to the patient.The bent and broken fastener and k-wire were fully removed.

• Brand Name: 8.0 X 165MM CANN SCREW FASTENER FULL THD
• Common Device Name: 8.0 X 165MM CANN SCREW FASTENER FULL THD
• Manufacturer (Section D): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 w 300 n; suite 150; logan UT 84321
• Manufacturer (Section G): OSTEOCENTRIC TECHNOLOGIES, INC; 75 w 300 n; suite 150; logan 84321
• Manufacturer Contact: todd evans ; 75 w 300 n; suite 150; logan, UT 84321 ; 4357572253
• MDR Report Key: 22073586
• Report Number: 3011656326-2025-00001
• Device Sequence Number: 18318635
• Product Code: HWC
• UDI-Device Identifier: 00810074306720
• UDI-Public: (01)00810074306720
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K211290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 380-5165-001
• Device Catalogue Number: 380-5165-001
• Device Lot Number: GEH093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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: 23 YR
• Patient Sex: Female