MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX ABC CE MARK 1 PCK; BONE CEMENT

Catalog Number 61969001

Device Problems Component Missing (2306); Out-Of-Box Failure (2311); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/31/2016

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.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It is reported that when operating room staff opened the external box of simplex cement, no ampoule was found inside of original package.

Manufacturer Narrative

An event regarding a missing ampoule from the box involving simplex bone cement was reported.The event was confirmed.Method & results: -device evaluation and results: the returned single pack of bone cement was inspected.The powder pouch was in situ and the liquid ampoule and its blister pack was missing.-medical records received and evaluation: not performed as there was no patient involvement.-device history review: the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: the simplex manufacturing cell reviewed the event and the investigation completed concluded that the review of existing process controls and data within manufacturing records for fg lot blw043 provides supporting data and evidence that it is highly unlikely that the simplex packaging process causes the event where the customer reported that a blistered liquid ampoule was missing from a unit carton within lot blw043.It is possible that the ampoule blister pack may have been removed from the unit carton by a previous user, perhaps to replace a broken or spilled ampoule of monomer from another unit carton and the next user to select this unit carton noticed that the ampoule missing.No further investigation for this event is possible at this time.

Event Description

It is reported that when or staff opened the external box of simplex cement, no ampoule was found inside of original package.

• Brand Name: SIMPLEX ABC CE MARK 1 PCK
• Type of Device: BONE CEMENT
• 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: 5664548
• MDR Text Key: 46221784
• Report Number: 0002249697-2016-01648
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 61969001
• Device Lot Number: BLW043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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