MAUDE Adverse Event Report: MAKO SURGICAL CORP. REAMER HANDLE, OFFSET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 212760

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)

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

Event Date 02/01/2023

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

Offset reamer will not slide into the end effector, gets stuck halfway and requires extreme force to remove it.Also several screws missing from the assembly.Case type / application: tha.

Event Description

Offset reamer will not slide into the end effector, gets stuck halfway and requires extreme force to remove it.Also several screws missing from the assembly.Case type / application: tha.

Manufacturer Narrative

Reported event: an event regarding mechanical failure involving a mako reamer handle was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection confirms shaft damage resulting in insertion issue as well as missing screws 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.

• Brand Name: REAMER HANDLE, OFFSET
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16405837
• MDR Text Key: 310165426
• Report Number: 3005985723-2023-00037
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032142
• UDI-Public: 00848486032142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141989
• 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: 04/11/2023

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
• Device Operator: Health Professional
• Device Model Number: 212760
• Device Catalogue Number: 212760
• Device Lot Number: 5259075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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