MAUDE Adverse Event Report: MAKO SURGICAL CORP. RAIL CLAMP ASSEMBLY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	210040
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
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.Device not returned.
Event or Problem Description
Breaking of the retaining ring of the locking screw (slider fixing the leg holder to the operating bed).
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a mako leg holder was reported.The event was confirmed based on the photograph that was provided.Method & results -product evaluation and results: the device was not returned however a photograph was provided that confirms the reported event; the housing around the screw is broken.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 23-aug-2017 with no relevant reported discrepancies.-complaint history review: there have been 11 other similar events for the lot referenced.Conclusions: the device was not returned however a photograph was provided that confirms the reported event; the housing around the screw is broken.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
Breaking of the retaining ring of the locking screw (slider fixing the leg holder to the operating bed).

• Brand Name: RAIL CLAMP ASSEMBLY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10992828
• Report Number: 3005985723-2020-00384
• Device Sequence Number: 13647505
• Product Code: OLO
• UDI-Device Identifier: 00848486031831
• UDI-Public: 00848486031831
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: 210040
• Device Catalogue Number: 210040
• Device Lot Number: 19050417
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other