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

Model Number	DR-432NS-04N
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation is ongoing.Once additional information is received, a supplemental will be filed accordingly.
Event or Problem Description
It was reported that during a surgery, a my 3d personalized reconstruction drill bit had dulled during use, and it was reported that the bone looked discolored.The procedure was able to be completed successfully.Additional information regarding this event is not known at this time.This event will be reported to the fda as a malfunction.
Additional Manufacturer Narrative
During a my3d pelvic reconstruction case ((b)(4)) on (b)(6) 2023, the surgeon had difficulty drilling holes with the non-sterile 4.3mm x 200mm calibrated drill bits.Three drill bits were used and were reported to be dull.Additionally, after the drilling operation, black particles were reported to be seen around the drilled area.The drilling operation was able to be completed successfully using alternative drill bits.The issue captured in this complaint contributed to a surgical delay of 15 minutes to the case.Three my3d pelvic reconstruction drill bits were reported to be dull.It was reported that the patient had sclerotic bone, and the surgeon had to use three drill bits.The root cause of this issue could not be determined conclusively.It was noticed that debris was present after drilling, which could have been caused by drilling into existing hardware,drilling into sclerotic bone, etc.However, the cause could not be determined conclusively.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION
• Common Device Name: 4.3MM X 200MM NON-STERILE DRILL BIT
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 17101183
• Report Number: 3013450937-2023-00098
• Device Sequence Number: 7690416
• Product Code: LPH
• UDI-Device Identifier: B278DR432NS04N0
• UDI-Public: B278DR432NS04N0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: DR-432NS-04N
• Device Catalogue Number: DR-432NS-04N
• Device Lot Number: SC36032
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 09/08/2023
• 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 Sex: Unknown