MAUDE Adverse Event Report: ONKOS SURGICAL MY3D PERSONALIZED PELVIC RECONSTRUCTION; ANATOMIC MODEL

Model Number	AM-M3DMD-04N
Medical Device Problem Code	Device Reprocessing Problem (1091)
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 still ongoing.Once additional information is received, supplemental mdrs will be filed accordingly.Three mdrs were reported for this event in total, one for each of the case parts.The following mdrs were submitted for this event: 3013450937-2023-00094, 3013450937-2023-00096.
Event or Problem Description
It was reported on (b)(6)2023 that the pelvic implant and plastic instruments for a my 3d personalized pelvic reconstruction case were sterilized together.According to the my 3d personalized pelvic reconstruction ifu, the metal implant and plastic accessories are not intended to be sterilized together.The case consisted of two customized pelvic guides and one acetabular reconstruction implant.There were no issues with devices after sterilization, and the procedure was able to be completed successfully.This event will be reported to the fda as a malfunction, as the impact of sterilizing these components together is unknown.This record captures the first of the two customized pelvic guides in the case.
Additional Manufacturer Narrative
Device description and part numbers were corrected from customized pelvic guide (pv-guide-04n) to anatomic model (am-m3dmd-04n).It was reported that the pelvic implant and anatomic models for a my3d pelvic reconstruction case on 12 may 2023 were sterilized together.Discoloration was not reported to be seen on these parts post sterilization.The procedure was completed successfully without surgical delay.Visual, dimensional, functional and material analysis could not be conducted as the parts were not returnedfor investigation.A review of the dhrs from 3d systems and onkos for these devices did not reveal any issues that may have contributed to this complaint.All manufacturing and associated inspections were completed successfully.Sterilization batch record review was not performed as these implants and accessories are provided non-sterile.These parts undergo sterilization at the hospital prior to surgery.The my3d personalized pelvic reconstruction ifu was reviewed and specifies that the metal implant and plastic accessories should not be sterilized together.Three mdrs were reported for this event in total, one for each of the case parts.The following mdrs were submitted for this event: 3013450937-2023-00094, 3013450937-2023-00095, 3013450937-2023-00096.
Event or Problem Description
It was reported on 12 may 2023 that the pelvic implant and plastic instruments for a my3d personalized pelvic reconstruction case were sterilized together.According to the my3d personalized pelvic reconstruction ifu, the metal implant and plastic accessories are not intended to be sterilized together.The case consisted of two anatomic models and one acetabular reconstruction implant.There were no issues with devices after sterilization, and the procedure was able to be completed successfully.This event will be reported to the fda as a malfunction, as the impact of sterilizing these components together is unknown.This record captures the first of the two anatomic models in the case.

• Brand Name: MY3D PERSONALIZED PELVIC RECONSTRUCTION
• Common Device Name: ANATOMIC MODEL
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 17101109
• Report Number: 3013450937-2023-00095
• Device Sequence Number: 1907701
• Product Code: LPH
• UDI-Device Identifier: B278AMM3DMD04N0
• UDI-Public: B278AMM3DMD04N0
• 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 Expiration Date: 05/09/2023
• Device Model Number: AM-M3DMD-04N
• Device Catalogue Number: AM-M3DMD-04N
• Device Lot Number: C23-087-A
• 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
• Date Device Manufactured: 04/25/2023
• 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: Male