MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE STRAIGHT SAGITAL SAW; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	212186
Medical Device Problem Codes	Difficult to Insert (1316); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
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.
Event or Problem Description
The sales rep received the following message: "that attachment not work( it's not holding the saw blade).We cancel the second case today".
Additional Manufacturer Narrative
Reported event an event regarding locking mechanism failure involving a mako saw attachment was reported.The event was confirmed.Method & results -product evaluation and results: the device with locking mechanism failure was reviewed and evaluated.No further product inspection is required.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a product history review is not required it was confirmed that the failure mode did not occur due to a manufacturing or process related issue.-complaint history review: as per procedure for product complaint trend detection, the post market surveillance team analyses, monitors and collects complaint data based on a catalogue number and failure mode combination.If a trend is identified, the post market surveillance team will add it to the trend log for further investigation.Monitoring will be continued under the current quarterly trend review.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.H3 other text : device not returned.
Event or Problem Description
The sales rep received the following message: "that attachment not work( it's not holding the saw blade).We cancel the second case today"c update: locking mechanism failure occurred intra-operatively.Due to the failure, a following case was cancelled prior to any patient (anesthesia) involvement.

• Brand Name: 2.7 DEGREE STRAIGHT SAGITAL SAW
• Common Device Name: 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: 17985595
• Report Number: 3005985723-2023-00161
• Device Sequence Number: 7531175
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K143752
• 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): 02/08/2024

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 Catalogue Number: 212186
• Device Lot Number: 35090621 / 3518487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown