MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE STRAIGHT SAGITAL SAW; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 212186

Device Problems Device Slipped (1584); Activation, Positioning or Separation Problem (2906); Separation Problem (4043); Premature Separation (4045)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2019

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

The saw is coming loose from the saw attachments while cutting bone.Dr.Is requesting that all of his attachments be replaced because this has been happening frequently with all the attachments.Surgical delay = minutes.Case type: tka.Update: "this happened today with a straight and an offset attachment in the same case.We have had issues with the saw coming loose for the past week and today dr.(b)(6) decided he wanted all of the attachments replaced." "the blade did not fall out but it became loose while making cuts which made our cuts in accurate." surgical delay 3-5 min, left side.Update: "which cuts were inaccurate?-straight cuts were inaccurate how were the cuts inaccurate? (proud, deep, etc)the cuts were proud.What is the estimated discrepancy mentioned in the complaint? (tka angle(s) & mm)- about a mm off was the planar probe utilized to measure cut accuracy? no it was not- the trial did not fit- on the femur a/p.Are post-op x-rays available? (yes/no)- no.".

Manufacturer Narrative

Reported event: it was reported that the saw is coming loose from the saw attachments while cutting bone.Dr.Is requesting that all of his attachments be replaced because this has been happening frequently with all the attachments.Surgical delay = minutes.Product evaluation and results: product was not inspected as the product was not returned for evaluation.Product history review: device history records indicate (b)(4) were manufactured under lot 35060718 and (b)(4) were accepted into final stock on 08/28/2018.A review of qt-18-08-0103 revealed 02 rejected devices were re-inspected and accepted into final stock on 01/08/2019.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 212186, lot number 35060718 shows 3 additional complaints related to the failure in this investigation.The complaints are (b)(4).Conclusions: the failure could not be determined as the product was not available for 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.H3 other text : device not returned.

Event Description

The saw is coming loose from the saw attachments while cutting bone.Dr.Is requesting that all of his attachments be replaced because this has been happening frequently with all the attachments.Surgical delay = minutes.Case type: tka.Update: "this happened today with a straight and an offset attachment in the same case.We have had issues with the saw coming loose for the past week and today dr.(b)(6) decided he wanted all of the attachments replaced." "the blade did not fall out but it became loose while making cuts which made our cuts in accurate." surgical delay 3-5 min, left side.Update: " 1.Which cuts were inaccurate? straight cuts were inaccurate 2.How were the cuts inaccurate? (proud, deep, etc)the cuts were proud 3.What is the estimated discrepancy mentioned in the complaint? (tka angle(s) & mm) about a mm off 4.Was the planar probe utilized to measure cut accuracy? no it was not- the trial did not fit- on the femur a/p 5.Are post-op x-rays available? (yes/no) no".

Event Description

The saw is coming loose from the saw attachments while cutting bone.Dr.Is requesting that all of his attachments be replaced because this has been happening frequently with all the attachments.Surgical delay = minutes.Case type: tka.Update: "this happened today with a straight and an offset attachement in the same case.We have had issues with the saw coming loose for the past week and today dr.(b)(6) decided he wanted all of the attachments replaced." "the blade did not fall out but it became loose while making cuts which made our cuts in accurate." surgical delay 3-5 min, left side.Update: " 1.Which cuts were inaccurate?- straight cuts were inaccurate 2.How were the cuts inaccurate? (proud, deep, etc)the cuts were proud 3.What is the estimated discrepancy mentioned in the complaint? (tka ¿ angle(s) & mm)- about a mm off 4.Was the planar probe utilized to measure cut accuracy? no it was not- the trial did not fit- on the femur a/p 5.Are post-op x-rays available? (yes/no)- no.".

Manufacturer Narrative

Reported event: it was reported that the saw is coming loose from the saw attachments while cutting bone.Dr.Is requesting that all of his attachments be replaced because this has been happening frequently with all the attachments.Surgical delay = minutes.Product evaluation and results: functional inspection confirmed the event.The ratcheting mechanism is broken and thus does not allow the saw attachment to clamp down fully on the blade to keep it in place.Product history review: device history records indicate 50 devices were manufactured under lot 35060718 and devices were accepted into final stock.A review revealed rejected devices were re-inspected and accepted into final stock on.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 212186, lot number 35060718 shows 3 additional complaints related to the failure in this investigation.Conclusions: the failure was confirmed via functional inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: 2.7 DEGREE STRAIGHT SAGITAL SAW
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9328750
• MDR Text Key: 181971163
• Report Number: 3005985723-2019-00812
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212186
• Device Catalogue Number: 212186
• Device Lot Number: 35060718/3503645
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other