MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P SPEEDSET FULL DOSE 1 PACK; IMPLANT

Catalog Number 6192-1-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

The surgeon reported that the cement was setting too quickly.There were no adverse consequences and the surgery was completed but the surgeon was upset about the set time of the cement and returned 17 doses to the branch.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Manufacturer Narrative

An event regarding setting time involving simplex bone cement was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection and functional testing was completed on three retain samples of the reported lot.The results were satisfactory and within specification.-medical records received and evaluation: not performed as no medical records were received.-device history review: bmr review for the specified lot indicates that the devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been one other event for the lot referenced.Conclusions: the investigation concluded that the reported setting time issue cannot be confirmed.The mixing properties of the retain samples of the reported lot code were tested and show that all required specifications are met.The mixing characteristics and working properties of simplex bone cements are influenced primarily by the temperature of the liquid and powder components at the time of mixing and by the temperatures of the utensils with which it contacts during mixing e.G.Mixing bowls, cement introducers etc.Generally, higher temperatures accelerate the polymerization reaction and lower temperatures delay it.Other factors which can affect setting time are mixing technique (speed, use of vacuum, centrifugation), thoroughness of mixing, complete utilization of all of the powder & liquid and care to avoid inclusion of any extraneous material such as blood or sterilization solutions into the mix.Mixing process/technique issues are highlighted in the or handbook.Based on the laboratory results of the retain samples it is not possible to replicate this event.A capa trend analysis was conducted for the reported failure mode and concluded that simplex setting time issues may result from other factors not necessarily related to the product.No further investigation for this event is possible at this time.If additional information becomes available this investigation will be reopened.

Event Description

The surgeon reported that the cement was setting too quickly.There were no adverse consequences and the surgery was completed but the surgeon was upset about the set time of the cement and returned 17 doses to the branch.

• Brand Name: SIMPLEX P SPEEDSET FULL DOSE 1 PACK
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4808618
• MDR Text Key: 5833518
• Report Number: 0002249697-2015-01764
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 6192-1-001
• Device Lot Number: DAW002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other