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); Material Integrity Problem (2978)

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

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.

Event Description

The 112640, lot 120120 sz 40 liner impactor had damaged threads.The case was completed successfully using a second set.

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: consultation with the material analysis team confirmed the thread damage.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 indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been 2 other events for the lot referenced.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.If additional information becomes available, this investigation will be reopened.

Event Description

The 112640, lot 120120 sz 40 liner impactor had damaged threads.The case was completed successfully using a second set.

• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5173862
• MDR Text Key: 29352876
• Report Number: 3005985723-2015-00202
• 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: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2018
• Device Catalogue Number: 112640
• Device Lot Number: 120120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2013
• 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