MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209063

Device Problems Difficult or Delayed Positioning (1157); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2020

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.Device not returned.

Event Description

Mps reported that he was unable to get into rio set up position, arm kept locking.He tried shutting down, restarting, changing mics, did mics status,which passed, and arm would still not get into set up position.Arm was on the correct side but when the trigger was squeezed it would move a little then just lock up.Mps called after the fact and had already spoken with the fse.Patient was not under anesthesia.Surgery not to be completed robotically.Case type: tka.Surgical delay <= 15 minutes.Updated additional event description - "replacement for mics associated with complaint (b)(4).The system started failing with a cable connection error with the mics detailed above.".

Manufacturer Narrative

Reported issue: mps reported that he was unable to get into rio set up position, arm kept locking.He tried shutting down, restarting, changing mics, did mics status,which passed, and arm would still not get into set up position.Arm was on the correct side but when the trigger was squeezed it would move a little then just lock up.Mps called after the fact and had already spoken with the fse.Patient was not under anesthesia.Surgery not to be completed robotically.Case type: tka, procedure completed manually.Updated additional event description - replacement for mics.Updated received additional event information ""the system started failing with a cable connection error with the mics detailed above.Fse recommended replacing it".Surgical delay <= 15 minutes".Product inspection: the product was not evaluated as the product was unavailable for inspection capa has been raised for the same.Device history review: review of device history record indicate that (b)(4) devices were manufactured under lot 42030119 and (b)(4) accepted and (b)(4) rejected on 27 february 2019.Review of qt revealed that the non conformance is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42030119 shows no additional complaints related to the failure in this investigation.Conclusion: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.¿ if additional information is received then the complaint will be reopened.H3 other text : device not returned.

Event Description

Mps reported that he was unable to get into rio set up position, arm kept locking.He tried shutting down, restarting, changing mics, did mics status,which passed, and arm would still not get into set up position.Arm was on the correct side but when the trigger was squeezed it would move a little then just lock up.Mps called after the fact and had already spoken with the fse.Patient was not under anesthesia.Surgery not to be completed robotically.Case type: tka.Surgical delay <= 15 minutes.Updated additional event description - "replacement for mics associated with complaint (b)(4).The system started failing with a cable connection error with the mics detailed above.".

• Brand Name: HANDPIECE MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10234020
• MDR Text Key: 197988516
• Report Number: 3005985723-2020-00228
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42030119 / 4205786
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other