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

Model Number	112680
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
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
(b)(6) (mps) reported that : "during the femoral tibial pins, the tibial pins stabilizer and the pins were stuck together (pins removed from the patient as well as the pin 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 total knee arthroplasty mako system a0017400 rev.8.For inability or difficulty disassembling system elements indicates that the highest potential severity of harm is s2 with a potential occurrence level o2 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.
Event or Problem Description
Mickael toledano (mps) reported that : "during the femoral tibial pins, the tibial pins stabilizer and the pins were stuck.Together (pins removed from the patient as well as the pin stabilizer".
Additional Manufacturer Narrative
Reported event: mps reported that : "during the femoral tibial pins, the tibial pins stabilizer and the pins were stuck together (pins removed from the patient as well as the pin stabilizer." product evaluation and results: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 19560617 and accepted into final stock on 12/12/2017.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112680, lot number 19560617 shows 3 additional complaints related to the failure in this investigation.Pr id : (b)(4).Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.
Event or Problem Description
Mickael toledano (mps) reported that : "during the femoral tibial pins, the tibial pins stabilizer and the pins were stuck together (pins removed from the patient as well as the pin stabilizer.".

• 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: 9711028
• Report Number: 3005985723-2020-00086
• Device Sequence Number: 2353185
• Product Code: OLO
• UDI-Device Identifier: 00848486017903
• UDI-Public: 00848486017903
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 04/20/2020

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: 19560617
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 03/31/2020; 04/20/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/13/2020; 04/20/2020
• 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