MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLOFEMORAL- L- SZ 6; IMPLANT

Catalog Number 180406

Device Problems Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

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

Event Date 04/30/2015

Event Type  malfunction  

Event Description

Dr.(b)(6) was performing an isolated pf procedure.The case proceeded normally through bone preparation.After trailing a size 6l pf component and 35 patella the actual implants were visualized by the surgical team and opened for the circulating nurse.Upon physical evaluation of the size 6 left pf implant, the circulating nurse noted that the implant seemed to have a coating on it.(item number (b)(4) lot 23130911-01).It was noted that the implant did seem to have a film on it.Prior to opening the second ¿inner¿ package of the original implant, we obtained a second implant and opened this implant to the circulating nurse.(item number (b)(4) lot 364360-m) upon visual inspection, the same ¿film¿ or powder was noted on this implant.Having only these two implants, the decision was made to use the original implant (item number (b)(4) lot 26130911-01) to complete the case.Prior to implanting the component was thoroughly washed with a solution of bacitracin and normal saline.After washing the implant was visually inspected for debris and none were noted.The implant was then implanted per standard procedure and the case was completed without further issue.Sales rep provided that surgical delay was 3 minutes.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

Review of the device history records indicates the lot was manufactured and accepted into final stock on 18-oct-2011.There have been no other events for the lot referenced.The device was received for evaluation inside the inner sterile blister pack.White particulate debris was observed on the clear plastic of the blister pack and on the surface of the implant.The event was confirmed.The investigation concluded the reported product and issue to be within the scope of legacy mako capa initiated to address debris observed in the inner sterile blister packs of patellofemoral implants.The packaging design was updated as a corrective action for the issue.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Dr.(b)(6) was performing an isolated pf procedure.The case proceeded normally through bone preparation.After trailing a size 6l pf component and 35 patella the actual implants were visualized by the surgical team and opened for the circulating nurse.Upon physical evaluation of the size 6 left pf implant, the circulating nurse noted that the implant seemed to have a coating on it.(item number 180406 lot 23130911-01).It was noted that the implant did seem to have a film on it.Prior to opening the second "inner" package of the original implant, we obtained a second implant and opened this implant to the circulating nurse.(item number 180406 lot 364360-m) upon visual inspection, the same "film" or powder was noted on this implant.Having only these two implants, the decision was made to use the original implant (item number 180406 lot 26130911-01) to complete the case.Prior to implanting the component was thoroughly washed with a solution of bacitracin and normal saline.After washing the implant was visually inspected for debris and none were noted.The implant was then implanted per standard procedure and the case was completed without further issue.Sales rep provided that surgical delay was 3 minutes.

• Brand Name: MCK PATELLOFEMORAL- L- 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4796504
• MDR Text Key: 20149173
• Report Number: 3005985723-2015-00086
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 180406
• Device Lot Number: 23130911-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2011
• 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