MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY- RIO BASE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	112227
Medical Device Problem Codes	Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During distal cut (1st cut performed), the cutter shifted going from the lateral to medial side cutting the medial side deeper.The surgeon stopped and said it didn¿t look right so we pulled out the cutter and checked the femur and cutter.The femur was fine but the cutter registered at 7.5mm.We checked discs and the base array and everything looked fine so we reregistered and placed a new distal attachment and saw blade.We passed again getting into the bone prep screen for the distal cut and the same issue occurred.The surgeon asked for manual instrumentation and to remove the robot.Upon inspecting everything, the base array itself looks to be the issue.It does not fasten securely because the spring mechanism is broken.Can i please have an fse also come look at the robot to ensure it is working properly? surgical delay = 15 minutes.Tourniquet used.Update on 13/july/2022 wg: as reported via case number: (b)(4): mps reported inaccurate cuts.On a tka case, distal cut was noticeably off by about 5mm.Base array was lose and j2 bump stops were off.(b)(4): detailed maintenance inspection performed.Adjusted and calibrated j2 bump stop shock absorbers per manual.Verified arm accuracy and overall system condition.All checks and validation testing passed, no defects noted, system is ready for clinical use.
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.
Additional Manufacturer Narrative
Reported event.An event regarding crack/fracture involving a mako arrays was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection confirms the cross pin has broken on the rio base array causing it to not fit securely into the robotic arm.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 are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
During distal cut (1st cut performed), the cutter shifted going from the lateral to medial side cutting the medial side deeper.The surgeon stopped and said it didn¿t look right so we pulled out the cutter and checked the femur and cutter.The femur was fine but the cutter registered at 7.5mm.We checked discs and the base array and everything looked fine so we reregistered and placed a new distal attachment and saw blade.We passed again getting into the bone prep screen for the distal cut and the same issue occurred.The surgeon asked for manual instrumentation and to remove the robot.Upon inspecting everything, the base array itself looks to be the issue.It does not fasten securely because the spring mechanism is broken.Can i please have an fse also come look at the robot to ensure it is working properly? surgical delay = 15 minutes.Tourniquet used.Update 13/july/2022 wg: as reported via case number: (b)(4): mps reported inaccurate cuts.On a tka case, distal cut was noticeably off by about 5mm.Base array was lose and j2 bump stops were off.(b)(4): detailed maintenance inspection performed.Adjusted and calibrated j2 bump stop shock absorbers per manual.Verified arm accuracy and overall system condition.All checks and validation testing passed, no defects noted, system is ready for clinical use.

• Brand Name: ARRAY- RIO BASE
• Common Device Name: 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: perla zima ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 15160408
• Report Number: 3005985723-2022-00103
• Device Sequence Number: 5589454
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142530
• 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): 10/17/2022

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 Model Number: 112227
• Device Catalogue Number: 112227
• Device Lot Number: 191721220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown