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 Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

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.Review of the batch manufacturing records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one more event for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported to the marketing team that simplex with tobramycin was used during a case at (b)(6).Cement started to harden 4-5 min, which is earlier than the usual timing (6 min).Surgeon had to remove the implant and replace it with a smaller one due to the quick hardening of the cement.Update 12-mar-2017: the second time they had to mix the cement, sales specialist and scrub supervisor were present and they witnessed the cement hardening quick too.So they had to speed up the process of applying the cement.Both the cement had the same lot number.

Event Description

It was reported to the marketing team that simplex with tobramycin was used during a case at ttsh.Cement started to harden 4-5 min, which is earlier than the usual timing (6 min).Surgeon had to remove the implant and replace it with a smaller one due to the quick hardening of the cement.Update 12-mar-2017: the second time they had to mix the cement, sales specialist and scrub supervisor were present and they witnessed the cement hardening quick too.So they had to speed up the process of applying the cement.Both the cement had the same lot number.

Manufacturer Narrative

An event regarding setting time involving simplex with tobramycin bone cement was reported.The event was not confirmed.Conclusions: the investigation concluded that the reported setting time issue cannot be confirmed.The mixing properties of the returned and retain samples 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 samples it is not possible to replicate this event.

• 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: 7390647
• MDR Text Key: 104271327
• Report Number: 0002249697-2018-00946
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 61971010
• Device Lot Number: THY047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other