MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 111140

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

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.The event was confirmed by visual inspection.Method & results: -device evaluation and results: visual inspection: 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.Material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Even if the device was returned, the device is fractured and in its current condition would not be an accurate reflection of its original manufactured condition.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been one other similar event for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re- opened.

Event Description

The tip of the slap hammer broke off inside the trial femur.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8429996
• MDR Text Key: 139126206
• Report Number: 3005985723-2019-00243
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486002732
• UDI-Public: 00848486002732
• 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,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: 111140
• Device Lot Number: 06050317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• 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
• Patient Age: 60 YR