MAUDE Adverse Event Report: ONKOS SURGICAL JTS (JUVENILE TUMOR SYSTEM); JTS (NON-INVASIVE) DISTAL FEMORAL REPLACEMENT

Model Number C23-273

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.

Event Description

It was reported by dr.(b)(6) that c23-273 was shipped with the short tibial bearing smmltb02 instead of the passive tibial bearing smtbc01g.The surgery was delayed by 20 minutes as the surgical team modified the incorrect short tibial bearing, small (smmltb01) to mimic the intended box component - passive tibial bearing, small (smtbc01g).After, the surgery went as planned.

• Brand Name: JTS (JUVENILE TUMOR SYSTEM)
• Type of Device: JTS (NON-INVASIVE) DISTAL FEMORAL REPLACEMENT
• 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: andrew trinker ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17492356
• MDR Text Key: 320718268
• Report Number: 3013450937-2023-00147
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: C23-273
• Device Catalogue Number: C23-273
• Device Lot Number: C23-273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 12 YR
• Patient Sex: Male