MAUDE Adverse Event Report: MAKO SURGICAL CORP. BAR EXTENSION; STEREOTAXIC DEVICE, ROBOTICS

Model Number	210070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
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
Cpd found putting and cracking along the extension bar to the back leg holder.There is concern that splintering could continue and cause harm to patient or staff while in use.The hospital would like the piece replaced.Case type: tka.
Additional Manufacturer Narrative
Reported event: it was reported that "cpd found putting and cracking along the extension bar to the back leg holder.There is concern that splintering could continue and cause harm to patient or staff while in use.The hospital would like the piece replaced." the event was confirmed.Method & results: -device evaluation and results: visual inspection: the bar extension showed signs of wear.See attached image.-product history review: review of the device history records indicates (b)(4) device(s) were manufactured and accepted into final stock on 8-15-2018 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210070, lot 609557 shows 00 additional complaint(s) related to the failure in this investigation.Conclusion: the device was discovered during sterile processing and showed signs of wear.There was no surgical procedure associated with the reported event.Per d03391, preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved, and no actual or potential patient harm existed for the alleged event.This event meets the definition of preventive maintenance; no further investigation is required at this time.
Event or Problem Description
Cpd found putting and cracking along the extension bar to the back leg holder.There is concern that splintering could continue and cause harm to patient or staff while in use.The hospital would like the piece replaced.Case type: tka.

• Brand Name: BAR EXTENSION
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9513177
• Report Number: 3005985723-2019-00920
• Device Sequence Number: 2695349
• Product Code: OLO
• UDI-Device Identifier: 00848486031862
• UDI-Public: 00848486031862
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 210070
• Device Catalogue Number: 210070
• Device Lot Number: 609557
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/04/2020
• 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: Hospitalization