MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TAPER DISASSEMBLY FORK

Model Number	25107001E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause for the damage of the taper disassembly fork was unable to be determined.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture of the instrument or a nonconformance.
Event or Problem Description
During a revision surgery, a taper disassembly fork being used by the surgeon, dr.(b)(6), was damaged while two components were being separated.The damaged rendered the instrument unusable.A new instrument was obtained to continue the surgery.The failure of the instrument led to extended surgery time for the patient.
Event or Problem Description
During a revision surgery, a taper disassembly fork being used by the surgeon, (b)(6), was damaged while two components were being separated.The damaged rendered the instrument unusable.A new instrument was obtained to continue the surgery.The failure of the instrument led to extended surgery time for the patient.
Additional Manufacturer Narrative
The name of the initial reported in section e1 was initially reported as (b)(6).The correct name of the initial reporter hospital is (b)(6).The name has been corrected.
Additional Manufacturer Narrative
The device was evaluated by microport orthopedics.Their report stated the following: "visual inspection of the returned instrument reveals that one of the prongs on the fork has fractured, and the other prong is damaged as well.Manufacturing records show that this part was manufactured in 2017.Review of the device history record (dhr) for this lot indicated that this product met all established acceptance criteria throughout the manufacturing process.The dhr also contains the proper material certification for this product.This instrument was dimensionally characterized per the appropriate quality instructions.The damaged part was dimensionally inspected to account for all features outside of the damaged prongs.All critical characteristics not involving the damaged prongs were found to have met specification.All available evidence indicates that this device met specification during time of use.Based on all available information, there have been no manufacturing deviations identified for this part that would affect the performance of the device.This instrument is no longer functional a result of the exhibited damage.".
Event or Problem Description
During a revision surgery, a taper disassembly fork being used by the surgeon, dr.(b)(6), was damaged while two components were being separated.The damaged rendered the instrument unusable.A new instrument was obtained to continue the surgery.The failure of the instrument led to extended surgery time for the patient.

• Brand Name: ELEOS
• Common Device Name: TAPER DISASSEMBLY FORK
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10518645
• Report Number: 3013450937-2020-00133
• Device Sequence Number: 19500699
• Product Code: MDM
• UDI-Device Identifier: B27825107001E0
• UDI-Public: B27825107001E0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25107001E
• Device Catalogue Number: 25107001E
• Device Lot Number: 1488402
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 09/02/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/11/2020; 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR