MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE); STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	111645
Medical Device Problem Codes	Break (1069); Device Slipped (1584)
Health Effect - Clinical Codes	Deposits (1809); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the 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
At (b)(6) hospital with mr (b)(6), while removing tibial checkpoint following a mako tka the tip of the checkpoint broke off into the patients cortical bone.Approximately 3-5 mm remains in situ in the patients tibial tuberosity.Right mako triathlon.Tip of the tibial checkpoint remains in the patients bone.
Additional Manufacturer Narrative
Reported event: at (b)(6) hospital with (b)(6), while removing tibial checkpoint following a mako tka the tip of the checkpoint broke off into the patients cortical bone.Approximately 3-5 mm remains in situ in the patients tibial tuberosity.Right mako triathlon tip of the tibial checkpoint remains in the patients bone.Product evaluation: the product was not returned and available for evaluation.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: product history review was not performed as the lot number was incorrect.Complaint history review: complaint history review was not performed as the lot number was product history review was not performed as the lot number was incorrect.Conclusions: the failure could not be confirmed as the product was not returned.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.H3 other text : device not returned.
Event or Problem Description
At (b)(6) hospital with (b)(6), while removing tibial checkpoint following a mako tka the tip of the checkpoint broke off into the patients cortical bone.Approximately 3-5 mm remains in situ in the patients tibial tuberosity.Right mako triathlon tip of the tibial checkpoint remains in the patients bone.

• Brand Name: FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE)
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9191238
• Report Number: 3005985723-2019-00735
• Device Sequence Number: 19454500
• Product Code: OLO
• UDI-Device Identifier: 00848486029494
• UDI-Public: 00848486029494
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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: 111645
• Device Lot Number: 02272019-4
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 12/15/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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: 72 YR
• Patient Weight: 65