MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 6; IMPLANT

Catalog Number 180606

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

During a primary left knee procedure, when circulating nurse opened outer box for the tibial baseplate, the sterile inner packaging was found to be torn thereby questioning the sterility of the implant and was not used in surgery.Another implant of same size was readily available and was used to complete the surgery without delay or any adverse consequence.

Manufacturer Narrative

An event regarding packaging issue involving a mck baseplate was reported.The event was confirmed.Method & results: device evaluation and results: the product packaging, foams, implant stickers, ifu, tyvek pouches, and the device were returned.The reported event was confirmed.A section of the outer tyvek pouch was not sealed.Medical records received and evaluation: the event is not related to patient factors.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: a visual inspection confirmed the event.The section of the outer tyvek pouch was not sealed.This investigation falls in the scope of a capa.The capa was opened on 30-jun-2014 to address complaints related to the metal implant mck packaging where the pouch seal was found open and delaminated.Between feb and march 2014, 3 cso's were opened to address a non-conformance where the mylar/tyvek exhibited, damaged pouches.The pouches were identified prior to use, by the or staff, the units were not used but returned to mako for investigation.All of the non-conforming seals were for the pre-manufactured seals (purchased seals).Both the inner and outer pouch seals delaminated at the same location, this therefore exposed the base plate to atmospheric conditions and broke sterility.The non-conforming product was for mck tibia base plates only, and were packaged in the old packaging configuration (clam shell, double pouched).No further actions will be taken.Pouch packaging configuration replaced with thermoformed trays in 2012.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

During a primary left knee procedure, when circulating nurse opened outer box for the tibial baseplate, the sterile inner packaging was found to be torn thereby questioning the sterility of the implant and was not used in surgery.Another implant of same size was readily available and was used to complete the surgery without delay or any adverse consequence.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 6
• Type of Device: IMPLANT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4965392
• MDR Text Key: 23532612
• Report Number: 3005985723-2015-00139
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2016
• Device Catalogue Number: 180606
• Device Lot Number: 26080211-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR