MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	111651
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
Event or Problem Description
Right tha.After the wound was closed, i noticed that i forgot to remove the checkpoint pin placed on the outside of the greater trochanter of the right femur.Confirmed with a nurse / surgeon.The anesthesia was extended and the surgeon reopened and removed the checkpoint pin.There was no abnormality in the pin, and the wound was closed again as it was, and the procedure was completed.
Event or Problem Description
Right tha.After the wound was closed, i noticed that i forgot to remove the checkpoint pin placed on the outside of the greater trochanter of the right femur.Confirmed with a nurse / surgeon.The anesthesia was extended and the surgeon reopened and removed the checkpoint pin.There was no abnormality in the pin, and the wound was closed again as it was, and the procedure was completed.
Additional Manufacturer Narrative
Reported event: right tha.After the wound was closed, i noticed that i forgot to remove the checkpoint pin placed on the outside of the greater trochanter of the right femur.Confirmed with a nurse / surgeon.The anesthesia was extended and the surgeon reopened and removed the checkpoint pin.There was no abnormality in the pin, and the wound was closed again as it was, and the procedure was completed.Update: "the operation time was extended by about 30 minutes".Product evaluation and results: the alleged failure is not regarding the device failure.Product history review: product history review cannot be performed as lot no is not provided.Complaint history review: complaint history review cannot be performed as lot no is not provided.Conclusions: the alleged failure is not regarding the device failure.The checkpoint has been left inside by the surgeon and later removed, while our user guide states that the checkpoint should be removed before finishing up the surgery.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.H3 other text : device not returned.

• Brand Name: TIBIAL, CHECKPOINT, STERILE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10648470
• Report Number: 0002249697-2020-02070
• Device Sequence Number: 11414512
• Product Code: OLO
• UDI-Device Identifier: 00848486001353
• UDI-Public: 00848486001353
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 111651
• Device Catalogue Number: 111651
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 01/04/2021
• 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: Hospitalization; Other; Required Intervention