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

Catalog Number 212480

Device Problems Detachment of Device or Device Component (2907); Premature Separation (4045)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2019

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

Sawblades flew out of the attachment.Case type: tka.Surgical delay: x - =15 minutes.

Manufacturer Narrative

Follow-up #1 and final report submitted reported event: it was reported that sawblades flew out of the attachment.Case type: tka.Surgical delay: x =15 minutes.Product evaluation and results: visual inspection: the 212480 2.7 degree angled sagital saw shows light wear and tear (small scratches and burnish marks) on the device.There are also marks on the knob from where the wrench makes contact.A picture of the device is attached.Functional inspection: the 212480 angled saw (lot 35050119 / serial (b)(4)) easily locked into both the left and right orientations in a known good 209063 mics handpiece.A known good 116170 standard 2mm blade was installed in the 212480 angled saw; the locking knob turns but the clicking feeling associated with the ratcheting pawl locking could not be felt.The mics was powered on and the blade came loose after a few seconds.A picture of the device installed in a mics is attached.The failure mode ¿sawblades flew out of the attachment¿ was confirmed.Dimensional inspection: not performed as no dimensional failure is alleged.Material analysis: not performed as no material failure is alleged.Product history review: review of the device history records indicate (b)(4) were manufactured and 40 accepted into final stock on 02-05-2019 with no reported discrepancies.A review of qt 19-02-0015 revealed that the non conformance is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 212480, lot 35050119 shows 1 adfditional complaints related to the failure in this investigation.The complaint is pr: (b)(4).Conclusions: the failure is confirmed via functional inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.

Event Description

Sawblades flew out of the attachment.Case type: tka.Surgical delay: x =15 minutes.

• 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: 8871149
• MDR Text Key: 154137772
• Report Number: 3005985723-2019-00561
• 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
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• 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: 3505396 / 35050119
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR