MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; SLAP HAMMER

Lot Number	CN101847
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of the reported thread damage was not determined.Given that this is the first report of damaged threads on the slap hammer which was released for commercial use since 2019: the probable root cause for this incident is improper handling or use of the surgical instrument.The possibility of the surgeon cross-threading the slap hammer with an incompatible thread intraoperatively could not be ruled out.
Event or Problem Description
It was reported by (b)(6), an onkos sales representative, that a 63-year-old female patient with an eleos hinge knee replacement in the right-side knee underwent a revision surgery on (b)(6) 2024 due to a fracture of the lateral condyle which was sustained when the patient reportedly fell down the stairs.The femoral stem was unable to be extracted by doctor salaam due to thread damage on the slap hammer instrument.The patient's distal femur was therefore resected more than initially planned to remove the incarcerated stem; this issue resulted in a 1-hour extension of the surgery.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: SLAP HAMMER
• 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: yara neurauter ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 19693569
• Report Number: 3013450937-2024-00224
• Device Sequence Number: 12764793
• Product Code: KRO
• UDI-Device Identifier: B278K0002008E0
• UDI-Public: B278K0002008E0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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
• Device Lot Number: CN101847
• 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: 04/22/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL STEM; RIGHT RESURFACING FEMUR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female