MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111651
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
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
Tibial checkpoint tip broke off when removing it, a small piece was left in the bone and surgeon could not retrieve it.The remainder has been returned.Second tibial checkpoint used also bent on insertion and has also been returned.The procedure was a left tka mako.No patient harm was reported.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update.Reported event: tibial checkpoint tip broke off when removing it, a small piece was left in the bone and surgeon could not retrieve it.The remainder has been returned.Second tibial checkpoint used also bent on insertion and has also been returned.The procedure was a left tka mako.No patient harm was reported.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: product history review was not performed as the lot number was not provided.Complaint history review: complaint history review was not performed as the lot number was not provided.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
Tibial checkpoint tip broke off when removing it, a small piece was left in the bone and surgeon could not retrieve it.The remainder has been returned.Second tibial checkpoint used also bent on insertion and has also been returned.The procedure was a left tka mako.No patient harm was reported.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: tibial checkpoint tip broke off when removing it, a small piece was left in the bone and surgeon could not retrieve it.The remainder has been returned.Second tibial checkpoint used also bent on insertion and has also been returned.The procedure was a left tka mako.No patient harm was reported.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: product history review was not performed as the lot number was not provided.Complaint history review: complaint history review was not performed as the lot number was not provided.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
Tibial checkpoint tip broke off when removing it, a small piece was left in the bone and surgeon could not retrieve it.The remainder has been returned.Second tibial checkpoint used also bent on insertion and has also been returned.The procedure was a left tka mako.No patient harm was reported.

• Brand Name: TIBIAL, CHECKPOINT, STERILE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8177266
• Report Number: 3005985723-2018-00763
• Device Sequence Number: 19553202
• Product Code: OLO
• UDI-Device Identifier: 00848486001346
• UDI-Public: 00848486001346
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 111651
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 02/28/2019; 05/06/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 03/25/2019; 05/28/2019
• 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
• Patient Age: 60 YR