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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SURGICAL SIMPLEX CEMENT; BONE CEMENT
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STRYKER ORTHOPAEDICS-MAHWAH SURGICAL SIMPLEX CEMENT; BONE CEMENT Back to Search Results
Catalog Number 61910001
Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2017
Event Type  malfunction  
Manufacturer Narrative
Review of the batch manufacturing records indicate the (b)(4) packs were manufactured and accepted into final stock with no reported discrepancies.Lot cby012 is made up of powder lot 018ay1 and liquid lot 991mx which were also reviewed and no discrepancies noted.There have been no other similar events for the lot referenced.This device is not distributed in the us, however similar device is.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It is reported that a foreign item was found in the packaging of simplex p bone cement.The item has been found between the inner powder package and the outer package.The packaging was reported not to be damaged.When opening the packaging the foreign item touched the sterile part.
 
Manufacturer Narrative
An event regarding foreign matter found in the powder pouch involving simplex bone cement was reported.The event was confirmed through visual inspection.The report concluded: review of simplex p bone cent radiopaque powder pouch, catalog # 0700-2-136, lot code 018ay1 confirmed brown foreign material.Characterisation using stero microscopy and infrared spectroscopy identified foreign material as cardboard.In addition the simplex outer pouch containing the inner pouch was returned for analysis.There is a piece of brown material stuck to the inner pouch the foreign matter is being held in place with some tape.Medical records received and evaluation: not performed as no medical records were provided.Indicated all (b)(4) packs were manufactured and accepted into final stock on with no reported discrepancies.There have been no other similar events for the reported lot referenced.An event regarding foreign material was found in the packaging of simplex p bone cement powder.The mar concluded that review of simplex p bone cement radiopaque powder pouch, catalog # 0700-2-136, lot code 018ay1 confirmed brown foreign material.Characterisation using stero microscopy and infrared spectroscopy identified foreign material as cardboard.Nc was raised on for foreign matter on simplex powder pouch.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
It is reported that a foreign item was found in the packaging of simplex p bone cement.The item has been found between the inner powder package and the outer package.The packaging was reported not to be damaged.When opening the packaging the foreign item touched the sterile part.
 
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Brand Name
SURGICAL SIMPLEX CEMENT
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
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6875171
MDR Text Key87634122
Report Number0002249697-2017-02815
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2021
Device Catalogue Number61910001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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