MAUDE Adverse Event Report: MAKO SURGICAL CORP. INSERTER- STRAIGHT SHELL; HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U

Catalog Number 112710

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the cup inserter threads seem to strip while using with a cup trial.Another inserter was available.It was reported that there were no adverse consequences to the patient.

Manufacturer Narrative

An event regarding damaged threads involving a mako inserter was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection confirmed the reported event as the threads of the returned device were damaged.Examination of the threads with a material analysis engineer indicated that damage observed consistent with cross-threading.Medical records received and evaluation: no patient medical records were available for review.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there have been 02 other events for the lot referenced.Conclusions: a visual inspection shows that threads were damaged.Examination of the threads with a material analysis engineer indicated that damage observed consistent with cross-threading.If additional information become available, this investigation will be reopened.

Event Description

It was reported that the cup inserter threads seem to strip while using with a cup trial.Another inserter was available.It was reported that there were no adverse consequences to the patient.

• Brand Name: INSERTER- STRAIGHT SHELL
• Type of Device: HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6771962
• MDR Text Key: 82021806
• Report Number: 3005985723-2017-00360
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112802
• 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: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 112710
• Device Lot Number: 120087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• 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