MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209063

Device Problems Power Problem (3010); Non Reproducible Results (4029)

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

Event Date 05/08/2019

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

Case number: (b)(4), mps (b)(6) reported mics not getting power once in haptics.Case type: tka.Surgery was not completed robotically.Update: "< 30 min surgical delay.Procedure completed manually, last 2 angled cuts were done manually.

Manufacturer Narrative

Reported event: mics not getting power once in haptics.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Product history review: device history records indicate (b)(4) devices were manufactured under lot kompy and (b)(4) devices were accepted into final stock on 09/05/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 209063 in prodex lot kobpy shows 01 additional complaint(s) related to the failure in this investigation.Complaint (b)(4).Conclusions: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that nc 1414517 and capa 1450904 are associated with the failure mode reported in this event.

Event Description

Case number: (b)(4), mps (b)(6) reported mics not getting power once in haptics.Case type: tka.Surgery was not completed robotically.Update: "< 30 min surgical delay.Procedure completed manually, last 2 angled cuts were done manually.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8632957
• MDR Text Key: 145946463
• Report Number: 3005985723-2019-00371
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Device Lot Number: LOT: 42040818 SN:4204684
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization