MAUDE Adverse Event Report: MAKO SURGICAL CORP. TKA FORCE BALANCER; STEREOTAXIC DEVICE, ROBOTICS

Model Number	164206
Medical Device Problem Codes	Fracture (1260); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation is anticipated but not yet begun.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Pin has fallen out on the tension er.Case type: tka.Update: "was the patient under anesthesia? no".
Event or Problem Description
Pin has fallen out on the tension er.Case type: tka.Update: "was the patient under anesthesia? no".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving tka force balancer was reported.Conclusion: the device was discovered post-operatively.The reported device was returned for evaluation.Visual inspection indicates that the tka force balancer showed that the pin has fallen off the assembly.The product was not evaluated for material analysis as the product was unavailable for inspection.Capa 2127499 has been raised for lost product.If the device is returned then the complaint will be reopened.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.H3 other text : device not returned.

• Brand Name: TKA FORCE BALANCER
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8975565
• Report Number: 3005985723-2019-00657
• Device Sequence Number: 3079198
• Product Code: OLO
• UDI-Device Identifier: 00848486029784
• UDI-Public: 00848486029784
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K143752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 164206
• Device Catalogue Number: 164206
• Device Lot Number: ERDNJ7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 03/23/2020
• 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: Other