MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 160177

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

The blue plastic piece for the tibial impactor broke into two pieces during impaction of the tibial baseplate implant.A second impactor had a broken tip which was noticed on opening.Case type: pka.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• 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: bradley curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7546045
• MDR Text Key: 109308787
• Report Number: 3005985723-2018-00310
• 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: Initial
• Report Date: 05/25/2018

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 Catalogue Number: 160177
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other