MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - CE TOBRA FD 10-PK; BONE CEMENT

Catalog Number 61971010

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the batch manufacturing records indicates the devices were manufactured and accepted into final stock with no reported discrepancies.Lot tdy027 is made up of powder lot 0973d075 and liquid lot 834by which were also reviewed and no discrepancies noted.There have been no other similar events for the lot referenced.The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.A supplemental report will be submitted upon completion of the investigation.

Event Description

Setting time for simplex tobramycin antibiotic cement was too fast.

Event Description

Setting time for simplex tobramycin antibiotic cement was too fast.

Manufacturer Narrative

Additional information: returned to manufacturer on.An event regarding setting time involving simplex with tobramycin bone cement was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection and functional testing was completed on the three retained samples and three returned samples from the customer from the reported lot.The results were satisfactory and within specification.-medical records received and evaluation: not performed because this event is in relation to the setting time of the bone cement.Setting time relates to the preparation of the bone cement and as such is not patient related.-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: complaint history review confirmed that there has been no other similar event for the reported lot.Conclusions: the investigation concluded that the reported setting time issue cannot be confirmed.The mixing properties of the retained samples and the three returned samples from the customer of the reported lot code were tested and show that all required specifications are met.The mixing characteristics and working properties of surgical 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 and the returned samples from the customer it is not possible to replicate this event.No further investigation for this event is possible at this time.If additional information becomes available this investigation will be reopened.

• Brand Name: SIMPLEX P - CE TOBRA FD 10-PK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6973988
• MDR Text Key: 90785245
• Report Number: 0002249697-2017-03096
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 61971010
• Device Lot Number: TDY027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Date Manufacturer Received: 12/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other