MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 212480

Device Problems Mechanical Problem (1384); Non Reproducible Results (4029)

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

Event Date 12/19/2018

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

Stryker rep reported that the part failed during surgery.Tka was completed using traditional instrumentation.Surgical delay 50 minutes.Update: mr (b)(6) undertook his first ever tka earlier today.The case was going to plan until they were preparing to execute bone resections with the mako.When engaging power on the mics handpiece there was a quiet sound coming from the mics handpiece rather than the usual loud saw noise.Mako specialist troubleshot the mics and also the offset saw attachment (212480).Specialist tried the straight saw attachment, and this functioned properly.Then tried a new mics power tool with the suspect offset saw and again this failed.Due to hospital factors the second attachment kit was unavailable so the decision was made to convert to a manual (depuy pfc) knee replacement.This saw attachment has only ever been used once before.Not aware of any follow up intervention or adverse patient outcomes.

Event Description

Stryker rep reported that the part failed during surgery.Tka was completed using traditional instrumentation surgical delay 50 minutes.Mr (b)(6) undertook his first ever tka earlier today.The case was going to plan until they were preparing to execute bone resections with the mako.When engaging power on the mics handpiece there was a quiet sound coming from the mics handpiece rather than the usual loud saw noise.Mako specialist trouble shot the mics and also the offset saw attachment (212480).Specialist tried the straight saw attachment, and this functioned properly.Then tried a new mics power tool with the suspect offset saw and again this failed.Due to hospital factors the second attachment kit was unavailable so the decision was made to convert to a manual (depuy pfc) knee replacement.This saw attachment has only ever been used once before.Surgical delay of 50 minutes.Not aware of any follow up intervention or adverse patient outcomes.Tka was completed using traditional instrumentation.

Manufacturer Narrative

Reported event: stryker rep reported that the part failed during surgery.Tka was completed using traditional instrumentation surgical delay 50 minutes.Update: mr (b)(6) undertook his first ever tka earlier today.The case was going to plan until they were preparing to execute bone resections with the mako.When engaging power on the mics handpiece there was a quiet sound coming from the mics handpiece rather than the usual loud saw noise.Mako specialist trouble shot the mics and also the offset saw attachment (212480).Specialist tried the straight saw attachment, and this functioned properly.Then tried a new mics power tool with the suspect offset saw and again this failed.Due to hospital factors the second attachment kit was unavailable so the decision was made to convert to a manual (depuy pfc) knee replacement.This saw attachment has only ever been used once before.Surgical delay of 50 minutes.Not aware of any follow up intervention or adverse patient outcomes.Tka was completed using traditional instrumentation functional inspection: functional inspection could not be performed because the product was not returned.Visual inspection: visual inspection could not be performed because the product was not returned.Dimensional inspection: dimensional inspection could not be performed because the product was not returned.Material analysis: material analysis could not be performed because the product was not returned.Product history review: product history review respectively shows the number of devices manufactured, devices that failed inspection, and their nc/npr/qt numbers if applicable.Date inspected: 05-09-2018, devices manufactured: 42, devices failed inspection: 13, nc/npr/qt numbers: qt18-05-0030.Product history review shows the non-conformance(s) is/are not related to the failure alleged in this complaint.Complaint history review: a review of complaints related to p/n: 212480, lot number: 35060118 shows no additional complaint(s) related to the failure in this investigation.Complaints related to p/n: 212480 will be tracked by trend request# 1191.Conclusion: 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: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

Stryker rep reported that the part failed during surgery.Tka was completed using traditional instrumentation surgical delay 50 minutes update: mr (b)(6) undertook his first ever tka earlier today.The case was going to plan until they were preparing to execute bone resections with the mako.When engaging power on the mics handpiece there was a quiet sound coming from the mics handpiece rather than the usual loud saw noise.Mako specialist trouble shot the mics and also the offset saw attachment (212480).Specialist tried the straight saw attachment, and this functioned properly.Then tried a new mics power tool with the suspect offset saw and again this failed.Due to hospital factors the second attachment kit was unavailable so the decision was made to convert to a manual (depuy pfc) knee replacement.This saw attachment has only ever been used once before.Surgical delay of 50 minutes.Not aware of any follow up intervention or adverse patient outcomes.Tka was completed using traditional instrumentation.

• Brand Name: 2.7 DEGREE ANGLED SAGITAL SAW
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8205126
• MDR Text Key: 131926228
• Report Number: 3005985723-2018-00802
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032128
• UDI-Public: 00848486032128
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212480
• Device Lot Number: 3503178/35060118
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization