MAUDE Adverse Event Report: ONKOS SURGICAL MY3D PERSONALIZED PELVIC RECONSTRUCTION; 4.3 X 200MM CALIBRATED DRILL BIT

Lot Number	J001777
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	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by (b)(6), an onkos sales representative, that a 4.3 x 200mm drill bit fractured intraoperatively in the process of implanting a my3d acetabular reconstruction implant (case # (b)(6)).The drill bit fragment(s) reportedly remain implanted in the patient.
Additional Manufacturer Narrative
The incident remains under investigation.Additional findings will be submitted upon discovery via supplemental report.
Event or Problem Description
It was reported by (b)(6), an onkos sales representative, that a 4.3 x 200mm calibrated drill bit fractured intraoperatively on (b)(6) 2024 while the surgeon, doctor (b)(6), was drilling screw holes to implant a my3d pelvic reconstruction system (case # c23-797) into a 75-year-old female patient.The fractured drill bit fragments reportedly remain implanted in the patient.
Additional Manufacturer Narrative
Based on review of device history records, the investigation concluded that the root cause of the reported mechanical failure (fracture) of the surgical instrument was not related to the design, manufacture, and/or sterilization of the 4.3 x 200mm calibrated drill bits.Results obtained through a physical evaluation of samples from the same lot which were held at onkos indicated that the most probable root cause which led to the fractured drill bits is unintended use error involving excessive bending of the drill bits.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION
• Common Device Name: 4.3 X 200MM 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: 19293567
• Report Number: 3013450937-2024-00124
• Device Sequence Number: 12959801
• Product Code: LPH
• 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,Followup
• Report Date (Section B): 07/25/2024

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
• Device Lot Number: J001777
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female