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

Catalog Number 209063

Device Problems Break (1069); Non Reproducible Results (4029)

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

Event Date 12/05/2018

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

Mics handpiece stopped working after our first 2 cuts.The misc was getting power but would not cut.After swapping out misc we notice the inner gear was broken and fell out surgical delay- =15 minutes, case type: tka.Update per rep: no debris was left in pt.Yes, the inner mics gear fell out while changing out the saw attachments.

Event Description

Mics handpiece stopped working after our first 2 cuts.The misc was getting power but would not cut.After swaping out misc we notice the inner gear was broken and fell out surgical delay- =15 minutes, case type: tka.Update per rep: no debris was left in pt?.Yes, the inner mics gear fell out while changing out the saw attachments.

Manufacturer Narrative

Reported event: it was reported that mics handpiece stopped working after our first 2 cuts.The misc was getting power but would not cut.After swaping out misc we notice the inner gear was broken and fell out.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: device history records indicate 25 devices were manufactured under lot k0bw0 and were accepted into final stock on 09/27/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, prodex lot k0bw0, shows no additional complaint(s) related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.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.

• 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: 8196824
• MDR Text Key: 131490018
• Report Number: 3005985723-2018-00775
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• 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: 42010918 /4204863
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization