MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL STD LM/RL SIZE 7; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 170507

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported: "the tip of the slap hammer broke off inside the trial femur.".

Manufacturer Narrative

An event regarding crack/fracture involving a mako slap hammer was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.The reported device was not returned however a photograph was provided for review.From the photograph provided there is evidence that the slap hammer has fractured and that the fractured piece is stuck in the femoral trial component.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported: "the tip of the slap hammer broke off inside the trial femur.".

• Brand Name: FEMORAL TRIAL STD LM/RL SIZE 7
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8429214
• MDR Text Key: 139091704
• Report Number: 3005985723-2019-00239
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003524
• UDI-Public: 00848486003524
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

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: 170507
• Device Lot Number: 26230912
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR