MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 3-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180703-1

Device Problems Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

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 Description

During the final impaction of the insert, the surgeon was not able to fully seat the actual insert.He had it removed and replaced with a new piece but he had the same outcome as shown on the attached photo "before further impaction" despite clearing away the surrounding tissues.This process repeated thrice and for the final insert he decided to do a further impact from the medial side and thus the final result as shown in attachment "after further impaction".A thin visible gap at the medial side can still be seen after the final further impaction.As we have exhausted all our 3x8mm polys that was prep for this case, the final poly had to be a 9mm instead.(b)(6) 2021 update: the patient was well at the moment and was discharged home.(b)(6) 2021 update: 3 attempts and 2 inserts were wasted.Lot number: 12141118-1, 12101118-1 actual insert used to complete the case, catalog number: 180703-2, lot number: 12551118-1.

Event Description

During the final impaction of the insert, the surgeon was not able to fully seat the actual insert.He had it removed and replaced with a new piece but he had the same outcome as shown on the attached photo "before further impaction" despite clearing away the surrounding tissues.This process repeated thrice and for the final insert he decided to do a further impact from the medial side and thus the final result as shown in attachment "after further impaction".A thin visible gap at the medial side can still be seen after the final further impaction.As we have exhausted all our 3x8mm polys that was prep for this case, the final poly had to be a 9mm instead.(b)(6) 2021 update: the patient was well at the moment and was discharged home.(b)(6) 2021 update : 3 attempts and 2 inserts were wasted.Lot number : 12141118-1,12101118-1 actual insert used to complete the case, catalog number: 180703-2, lot number : 12551118-1.

Manufacturer Narrative

Reported event.An event regarding seating/locking issues involving a mako insert was reported.The event was not confirmed.Method & results.-product evaluation and results: visual inspection: the device was not received for review however photographs of the device were provided.Visual inspection of the photographs of the device indicated that the device is in used condition.Dents and scratches were observed on the surface of the device.Damage is consistent with attempted implantation/explantation.No further surface discrepancies were observed.Additionally, an intraoperative photo was provided that shows an obvious gap between insert and baseplate.However, no conclusive decision can be made based on the provided photo.Material analysis, functional, and dimensional inspections could not be performed as the device was not available for testing.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on january 8, 2019 with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that during the final impaction of the insert, the surgeon was not able to fully seat the insert.The device was not received for review however photographs of the device were provided.Visual inspection of the photographs of the device indicated that the device is in used condition.Dents and scratches were observed on the surface of the device.Damage is consistent with attempted implantation/explantation.No further surface discrepancies were observed.Additionally, an intraoperative photo was provided that shows an obvious gap between insert and baseplate.However, no conclusive decision can be made based on the provided photo.The exact cause of the event could not be determined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

During the final impaction of the insert, the surgeon was not able to fully seat the actual insert.He had it removed and replaced with a new piece but he had the same outcome as shown on the attached photo "before further impaction" despite clearing away the surrounding tissues.This process repeated thrice and for the final insert he decided to do a further impact from the medial side and thus the final result as shown in attachment "after further impaction".A thin visible gap at the medial side can still be seen after the final further impaction.As we have exhausted all our 3x8mm polys that was prep for this case, the final poly had to be a 9mm instead.10 aug 2021 update: the patient was well at the moment and was discharged home.19 aug 2021 update : 3 attempts and 2 inserts were wasted.Lot number : 12141118-1,12101118-1 actual insert used to complete the case, catalog number: 180703-2, lot number : 12551118-1.

Manufacturer Narrative

Reported event.An event regarding seating/locking issues involving a mako insert was reported.The event was not confirmed.Method & results.-product evaluation and results: visual inspection: visual inspection of the device indicated that the device is in used condition.Dents and scratches were observed on the surface of the device.Damage is consistent with attempted implantation/explantation.No further surface discrepancies were observed.Additionally, an intraoperative photo was provided that shows a gap between insert and baseplate.However, no conclusive decision can be made based on the provided photo.Dimensional & functional inspection: dimensional and functional inspections were not performed as the device was returned damaged from the implantation/explantation attempts; any results received from a dimensional/functional inspection would not be reflective of the manufactured state of the device.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that during the final impaction of the insert, the surgeon was not able to fully seat the insert.Visual inspection of the device indicated that the device is in used condition.Dents and scratches were observed on the surface of the device.Damage is consistent with attempted implantation/explantation.No further surface discrepancies were observed.Additionally, an intraoperative photo was provided that shows a gap between insert and baseplate.However, no conclusive decision can be made based on the provided photo.Dimensional and functional inspections were not performed as the device was returned damaged from the implantation/explantation attempts; any results received from a dimensional/functional inspection would not be reflective of the manufactured state of the device.The exact cause of the event could not be determined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MCK TIBIAL ONLAY INSERT-SZ 3-8MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12384652
• MDR Text Key: 268704758
• Report Number: 3005985723-2021-00151
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486000851
• UDI-Public: 00848486000851
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K082172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2023
• Device Model Number: 180703-1
• Device Catalogue Number: 180703-1
• Device Lot Number: 12101118-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female