MAUDE Adverse Event Report: ONKOS SURGICAL MY3D PERSONALIZED PELVIC RECONSTRUCTION; CALIBRATED DRILL BIT

Lot Number	J001778
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of this incident was not definitively determined.Based on review of the device history records, the investigation concluded that the root cause was not related to the design, manufacture, and/or sterilization of the instrument.The instrument malfunction was able to be reproduced using samples from the same lot via unintended use error.
Event or Problem Description
It was reported by (b)(4), an onkos sales representative, that two 4.3 x 200mm drill bits fractured intraoperatively on (b)(6) 2024 in the process of implanting a my3d acetabular reconstruction implant (case # (b)(4)) into a 79-year-old male patient.Drill bit fragments reportedly remain implanted in the patient.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION
• Common Device Name: CALIBRATED DRILL BIT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 19387906
• Report Number: 3013450937-2024-00153
• Device Sequence Number: 4071551
• Product Code: KRO
• UDI-Device Identifier: B278DR4320004N0
• UDI-Public: B278DR4320004N0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212815
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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
• Device Lot Number: J001778
• 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: 04/23/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• 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: 4.3 X 200MM CALIBRATED DRILL BIT; PATIENT SPECIFIC PELVIC IMPLANT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male