MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number UNK_OFL

Device Problems Appropriate Term/Code Not Available (3191); Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2020

Event Type  malfunction  

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 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.".

Manufacturer Narrative

Reported event: "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: 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 device history records cannot be conducted as the lot number and catalog are unknown.Complaint history review: review of the complaint history records cannot be conducted as the lot number and catalog are unknown.Conclusion: 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 cannot be conducted as the catalog number is unknown h3 other text : device not returned.

Event 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".

Event 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".

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.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9711189
• MDR Text Key: 179510328
• Report Number: 3005985723-2020-00087
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization