MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 111653

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/22/2022

Event Type  Injury  

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

As reported: "checkpoint was left in greater troch and removed post op.Surgical delay > 30 minutes.Case type / application: tha" spoke to mps.After surgery was complete and the patient was out of the o.R., post-op x-ray showed the checkpoint left in the patient.Patient was brought back into the o.R., put back under anesthesia, and the checkpoint was removed.There was no intra-operative delay, mps was trying to report that the removal took > 30 minutes.Mps may be able to provide some additional patient information.

Event Description

As reported: "checkpoint was left in greater troch and removed post op.Surgical delay > 30 minutes.Case type / application: tha" spoke to mps.After surgery was complete and the patient was out of the o.R., post-op x-ray showed the checkpoint left in the patient.Patient was brought back into the o.R., put back under anesthesia, and the checkpoint was removed.There was no intra-operative delay, mps was trying to report that the removal took > 30 minutes.Mps may be able to provide some additional patient information.

Manufacturer Narrative

Reported event: an event regarding other involving a mako checkpoint was reported.The event was not confirmed because the product was not available for inspection.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-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 not confirmed because 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 : not available.

• Brand Name: CHECKPOINT, 3.5 HEX IMPACTION STERILE
• 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: 14135862
• MDR Text Key: 289442902
• Report Number: 3005985723-2022-00047
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486017316
• UDI-Public: 00848486017316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 111653
• Device Catalogue Number: 111653
• Device Lot Number: W75839-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2021
• 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): Required Intervention
• Patient Sex: Female