MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P SPEEDSET FULL DOSE 1 PACK; BONE CEMENT, ANTIBIOTIC

Catalog Number 6192-1-001

Device Problems Device Expiration Issue (1216); Shelf Life Exceeded (1567)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Hospital staff opened expired bone cement while sales rep was out of the room getting proper sized implant.

Manufacturer Narrative

An event regarding opening of expired product involving simplex p speed set bone cement was reported.Conclusion: a review of the packaging label of the reported product indicates an expiry date of 2015-05 (may 2015).This product was reportedly attempted to be used in surgery on (b)(6) 2016 however it was noted to be expired product before implantation and it was subsequently not used.It is the responsibility of the user to verify the expiration date and as such was the case in this event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Hospital staff opened expired bone cement while sales rep was out of the room getting proper sized implant.

• Brand Name: SIMPLEX P SPEEDSET FULL DOSE 1 PACK
• Type of Device: BONE CEMENT, ANTIBIOTIC
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5452075
• MDR Text Key: 39152881
• Report Number: 0002249697-2016-00492
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 6192-1-001
• Device Lot Number: DHU018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2013
• 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