MAUDE Adverse Event Report: ONKOS SURGICAL INC. MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM; CUSTOMIZED PELVIC GUIDE

Catalog Number	PV-GUIDE-04N
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is still under investigation.A supplemental mdr will be submitted once additional information is received.
Event or Problem Description
It was reported that during a my3d personalized pelvic reconstruction case, the surgeon had difficulty reaming out the bone with the customized pelvic guide (reaming guide).It was reported that there was difficulty in the orientation of the guide while reaming, and it resulted in over an hour surgical delay.Due to the length of surgical delay, this event will be reported to the fda as a serious injury.This record captures the customized pelvic guide.
Additional Manufacturer Narrative
During a my3d personalized pelvic reconstruction case, it was reported that a surgeon had difficulty reaming the patient's bone with the reaming guide.As a result, the surgeon had to ream by hand with a midas burr.This caused a surgical delay of an hour; however, the surgery was completed successfully.According to the my3d personalized pelvic reconstruction surgical technique, the acetabulum should be reamed with an acetabular reamer and subsequently checked for fit with the modular trial frame (customized pelvic guide) and modular trial cup (customized pelvic guide).The acetabulum is not advised to be reamed with the modular trial frame attached intraoperatively.It is likely that a fit issue occurred on the ream frame with the reamer, as it was not designed for use with the reamer.As this guidance is in the my3d personalized pelvic reconstruction surgical technique and was not followed, the failure mode for this event will be classified as use error.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM
• Common Device Name: CUSTOMIZED PELVIC GUIDE
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 17515629
• Report Number: 3013450937-2023-00148
• Device Sequence Number: 12149743
• Product Code: LPH
• UDI-Device Identifier: B278PVGUIDE04N0
• UDI-Public: B278PVGUIDE04N0
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K212815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/10/2023

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: 10/18/2023
• Device Catalogue Number: PV-GUIDE-04N
• Device Lot Number: C23-259-B
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Female