MAUDE Adverse Event Report: MAKO SURGICAL CORP. IMPACTOR-POLY LINER-40MM; HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U

Catalog Number 112640

Device Problems Break (1069); Degraded (1153)

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

Event Date 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the mako tha procedure with dr.(b)(6) hospital, (b)(6), it was noted the hex driver was stripped and also the 40 liner impactor had damaged threads.A backup liner impactor was used and the marchand used a rongeour to remove the variable angle screw.

Manufacturer Narrative

An event regarding damaged threads involving a mako impactor-poly liner-40mm was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection confirmed the thread damage and damage on the inner diameter of the device near the base of the inner threads indicated that the damage is due to improper technique when assembling the device with its corresponding impactor.Medical records received and evaluation: no patient medical records were available for review.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the investigation determined the likely root cause of the damage was due to improper technique when assembling the device and its corresponding impactor.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.

Event Description

During the mako tha procedure with dr.(b)(6) at (b)(6), it was noted the hex driver was stripped and also the 40 liner impactor had damaged threads.A backup liner impactor was used and the marchand used a rongeour to remove the variable angle screw.

• Brand Name: IMPACTOR-POLY LINER-40MM
• 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: 5378353
• MDR Text Key: 36739473
• Report Number: 3005985723-2016-00033
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122158
• 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: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 112640
• Device Lot Number: 120154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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