MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 219999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Slipped (1584); Positioning Problem (3009)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding inaccurate resection involving a mako pka software was reported.The event was not confirmed because the log/session files were not made available for review.Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided.-clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob1079 was inspected on (b)(6) 2020 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: rob1079 shows 0 similar complaints for pka software - inaccurate resection.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data are needed to complete the investigation for determining root cause.

Event Description

Immediately after completing bone preparation, and posterior bone fragments were removed it was observed that the popliteal tendon was nicked and bleeding.Bleeding was able to be isolated and sutured with minimal delay in the case.Surgeon was requesting further information about if there have been other reported incidents of similar occurrences to help establish which cut he may have caused the nick on.

• Brand Name: MAKO ROBOTIC ARM 3.1
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 11856022
• MDR Text Key: 252431017
• Report Number: 3005985723-2021-00092
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 219999
• Device Catalogue Number: 219999
• Device Lot Number: ROB1079
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other