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

Catalog Number 212760

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

"as part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted if additional information becomes available." h3 other text : not available.

Event Description

A screw fell out of the reamer handle case type / application: tha 4.1.

• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18697915
• MDR Text Key: 336412988
• Report Number: 3005985723-2024-00021
• 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: K170593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212760
• Device Lot Number: 5494250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2024
• 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