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

Model Number 112680

Device Problem Separation Failure (2547)

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

Event Date 01/03/2020

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

While drilling into bone, bone pin became stuck into bone stabilizer and will not come out.Case type: tka.Surgical delay: x < 15 minutes.

Manufacturer Narrative

Reported event: while drilling into bone, bone pin became stuck into bone stabilizer and will not come out.Case type: tka.Surgical delay: x <= 15 minutes.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: review of the product history records indicate (b)(4) devices were manufactured under lot no 19211016 and accepted into final stock on 06/07/2017.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 19211016 shows 05 additional complaints related to the failure in this investigation.The complaints are pr: (b)(4).Conclusions: 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: 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

While drilling into bone, bone pin became stuck into bone stabilizer and will not come out.Case type: tka.Surgical delay: x <= 15 minutes.

• 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: 9646688
• MDR Text Key: 184451401
• Report Number: 3005985723-2020-00056
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• 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: 19211016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization