MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY STABILIZER, SHORT, 4.0MM; STEREOTAXIC DEVICE, ROBOTICS

Model Number 112680

Device Problems Separation Failure (2547); Physical Resistance/Sticking (4012)

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

Event Date 01/14/2020

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

During tka, pin became stuck in stabilizer.Case type: tka.Update: was the bone pin in the patient when event occurred? yes.Did the bone pin break in the patient when the event occurred? no.

Manufacturer Narrative

Reported event: during tka, pin became stuck in stabilizer.Product evaluation and results: visual inspection confirmed the bone pin was stuck in the array stabilizer.Product history review: review of the device history records indicate (b)(4) devices were manufactured under lot no 19150315 and accepted into final stock on 08/27/2015.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112680, lot number 19150315 shows 03 additional complaints related to the failure in this investigation.Complaint id:(b)(4).Conclusions: the failure was confirmed as alleged via visual 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

During tka, pin became stuck in stabilizer.Case type: tka.Update: was the bone pin in the patient when event occurred? yes.Did the bone pin break in the patient when the event occurred? no.

• Brand Name: ARRAY STABILIZER, SHORT, 4.0MM
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9663264
• MDR Text Key: 177673599
• Report Number: 3005985723-2020-00072
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486017903
• UDI-Public: 00848486017903
• 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: 04/01/2020

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 Model Number: 112680
• Device Catalogue Number: 112680
• Device Lot Number: 19150315
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization