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

Catalog Number 170517

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Slap hammer screw broke off into the uni femur trial.Slap hammer end broke off into the uni femur trial.

Manufacturer Narrative

An event regarding crack/fracture of a mako slaphammer involving a mako trial was reported.Conclusions: it was reported that the tip of the slaphammer had fractured, with the fractured tip screwed into the trial.Based on the information provided there is no indication or allegation that the device reported in this investigation may have contributed to the event.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

Slap hammer screw broke off into the uni femur trial.

• Brand Name: FEMORAL TRIAL STD RM/LL 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: 8470419
• MDR Text Key: 140516712
• Report Number: 3005985723-2019-00268
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003609
• UDI-Public: 00848486003609
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

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: 170517
• Device Lot Number: 2362021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other