MAUDE Adverse Event Report: MAKO SURGICAL CORP. IMPACTOR-POLY LINER-36MM; HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U

Catalog Number 112636

Device Problems Break (1069); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The 32 and 36 liner impactor heads both were damaged and spun on the liner impactor shaft.We finished the case without delay of adverse affect.

Manufacturer Narrative

The event is regarding damaged threads involving a mako impactor was reported.The event was confirmed.Method & results: -device evaluation and results: damage was observed on the threads of the impactor consistent with cross threading with the mating instrument and most likely from field use.-medical records received and evaluation: no patient medical records were available for review.-device history review: review of the device history records indicate devices were manufactured and accepted into final stock on with no reported discrepancies.-complaint history review: there has been 1 other event for the lot referenced.Conclusions: the investigation confirmed that the device has damaged threads from field use.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

The 32 and 36 liner impactor heads both were damaged and spun on the liner impactor shaft.We finished the case without delay of adverse affect.

• Brand Name: IMPACTOR-POLY LINER-36MM
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5732618
• MDR Text Key: 47642609
• Report Number: 3005985723-2016-00189
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 112636
• Device Lot Number: 120080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: No
• 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