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

Catalog Number 61969010

Device Problems Break (1069); Out-Of-Box Failure (2311); Insufficient Information (3190)

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

Event Date 01/14/2016

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.An evaluation of the device cannot be performed as the device 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.

Event Description

The customer reported that "the antiotics was broken inside the packaging.".

Manufacturer Narrative

An event regarding packaging damage involving simplex bone cement with tobramycin was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no devices were returned and no photographs were provided.Medical records received and evaluation: not performed as there was no patient involvement.Device history review: review of the batch manufacturing record indicates that this batch was manufactured and shipped to stock with no reported discrepancies.Complaint history review: review determined that there were no other similar reported events for the lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return and/or photographs are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded simplex packaging damage may result from other factors not necessarily related to the product.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The customer reported that "the antiotics was broken inside the packaging.".

• Brand Name: SIMPLEX P - CE ABC FD 10-PK
• 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: 5419048
• MDR Text Key: 38288883
• Report Number: 0002249697-2016-00361
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 61969010
• Device Lot Number: BGW022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• 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