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

Catalog Number 209063

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Output Problem (3005)

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

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the 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 failed intra-op and then failed mics status check post-op.Case type: tka.Surgical delay: 30 minutes.Related (b)(4).Update: "we had one replacement and it also failed.We had to complete our final recut manually.".

Event Description

Mics failed intra-op and then failed mics status check post-op.Case type: tka.Surgical delay: 30 minutes.Related (b)(4).Update: "we had one replacement and it also failed.We had to complete our final recut manually.".

Manufacturer Narrative

Reported event: mics failed intra-op and then failed mics status check post-op.Product evaluation and results: the product was not evaluated 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.Product history review: device history records indicate (b)(4) were manufactured under lot k08cd and (b)(4) were accepted into final stock on 09/21/2016.A review of (b)(4) revealed that the issue is not related to the failure alleged in this compliant.Complaint history review a review of complaints related to parts in lot number k08cd, p/n 209063 shows 04 other complaints related to the failure in this investigation.Complaints pr (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 (b)(4) 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: 9165871
• MDR Text Key: 165474157
• Report Number: 3005985723-2019-00722
• 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: 12/26/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Device Lot Number: 42050816 / 4201086
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 11/30/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization