MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL CHECKPOINT - (STERILE); STEREOTAXIC DEVICE, ROBOTIDA

Catalog Number	111644
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
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
Dr.(b)(6) made a comment during a case that several months prior he had left in a femoral checkpoint during a pfj procedure.It was discovered on the patient¿s follow up visit to his office and removed within a couple days of discovery.Surgeon did not provide patient initials.Hospital does not provide post op x-rays.
Event or Problem Description
Dr.Welch made a comment during a case that several months prior he had left in a femoral checkpoint during a pfj procedure.It was discovered on the patient¿s follow up visit to his office and removed within a couple days of discovery.Surgeon did not provide patient initials.Hospital does not provide post op x-rays.
Additional Manufacturer Narrative
Reported event: it was reported that the checkpoint was left in the patient product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: product history review was not performed as the lot number was not provided.Complaint history review: complaint history review was not performed as the lot number was not provided.Conclusions: the failure could not be determined as the product was not available for inspection.If additional information is received the complaint will be reopened.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.

• Brand Name: FEMORAL CHECKPOINT - (STERILE)
• Common Device Name: STEREOTAXIC DEVICE, ROBOTIDA
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7557320
• Report Number: 3005985723-2018-00318
• Device Sequence Number: 1899277
• Product Code: OLO
• UDI-Device Identifier: 00848486029487
• UDI-Public: 00848486029487
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K170584
• 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): 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 111644
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 04/18/2019
• 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