MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY STABILIZER, SHORT, 4.0MM; STEREOTAXIC DEVICE, ROBOTICS

Model Number	112680
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
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.
Event or Problem Description
Customer reported that the pin jammed in stabilizer.
Event or Problem Description
Customer reported that the pin jammed in stabilizer.
Additional Manufacturer Narrative
When this decision was accessed it was done so through a different criteria.Upon further investigation the conclusion, per our risk documentation, has been updated and the below is the no report rationale.A review of the for partial knee arthroplasty mako system a0022859 rev 6.For inability or difficulty disassembling system elements indicates that the highest potential severity of harm is s2 with a potential occurrence level 02.Additionally, a review of the complaint history data for the past 4 years indicated there have been no reports of serious injury or death as a result of similar events with this device family.Based upon this review, it is unlikely that a serious injury or death would result if this event were to recur.Therefore, this event is not reportable.

• Brand Name: ARRAY STABILIZER, SHORT, 4.0MM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9694885
• Report Number: 3005985723-2020-00078
• Device Sequence Number: 2422399
• Product Code: OLO
• UDI-Device Identifier: 00848486017903
• UDI-Public: 00848486017903
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K142530
• 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): 04/21/2020

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: 112680
• Device Catalogue Number: 112680
• Device Lot Number: 19181117
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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