MAUDE Adverse Event Report: OMNILIFE SCIENCE APEX KNEE SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	KR-46000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint involved a patient who underwent a knee surgery on (b)(6) 2024.Doctor was drilling the tibia canal with a boss reamer.It was identified by the rep attending the surgery to the surgeon that a small part of the reamer was missing.The scrub nurse searched for the device and could not find it.The surgeon stated that if it is in the tibial he is not prepared to remove the tibial revision implant as it would be more detrimental to the patient.That they would x-ray post operatively if not found.Subsequent to surgery a post op x-ray was performed in recovery room identifying that the instrument is in the tibial shaft - distal to the tibial stem and not in contact as surrounded by palacos r antibiotic cement.This had been identified to the scrub at the start of the case, which is why a count of this item commenced prior to closing the surgical wound.Allowing the surgeon to intervene if he deemed appropriate.
Additional Manufacturer Narrative
This report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

• Brand Name: APEX KNEE SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): OMNILIFE SCIENCE; 480 paramount drive; raynham MA 02767
• Manufacturer (Section G): OMNILIFE SCIENCE; 480 paramount drive; raynham MA 02767
• Manufacturer Contact: jamie demedeiros ; 480 paramount drive; raynham, MA 02767 ; 5088226030
• MDR Report Key: 20692307
• Report Number: 1226188-2024-00188
• Device Sequence Number: 18282028
• Product Code: LXH
• UDI-Device Identifier: 00841690117841
• UDI-Public: 00841690117841
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: E522576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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 Catalogue Number: KR-46000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/14/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown