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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID Back to Search Results
Catalog Number 623-10-32E
Device Problems Packaging Problem (3007); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2018
Event Type  malfunction  
Manufacturer Narrative
Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that when they opened up the poly liner they noticed a sticky residue under between the paper layer and the outer plastic carton which looks like glue from the paper layer.They opened up a total of 4 liners with the glue residue and completed the case using a 5th liner.There was 5- 10 mins delay while new packages were opened.
 
Manufacturer Narrative
An event regarding glue reside on the inner blister involving a trident insert was reported.The event was confirmed by product inspection.Method & results: -product evaluation and results: the inner blister was returned with the box, ifu and device however, the tyvek sheet was not returned.Residue is visible on the center of the lid of the inner blister.A material engineer indicated that the debris from the sample was consistent with tyvek.See materials engineering request document in nc.-clinician review: not performed as medical records were not provided for review.-product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: 2 other events were reported for the lot indicated.Conclusions: the event for glue residue on the inner blister was confirmed by product inspection.Residue is visible on the center of the lid of the inner blister.A material engineer indicated that the debris from the sample was consistent with tyvek.Corrective action/preventive action: nc was created for tyvek sheet residue on inner blister lid.The nc noted, ¿the retainer within the inner sealed blister showed a white residue which is characterized as a glue-like substance (tyvek residue) on the retainer.The quality monitoring and post market surveillance team completed a fourier-transform infrared spectroscopy (ftir) test and confirmed that the substance is coming from the tyvek.The white substance is fixed on the retainer (no loose particulates) and, therefore, no substance would be in contact with the implant.The visual defect also does not affect the integrity of the sterile barrier system (sbs).Therefore, the sbs still meets its intent from a seal strength and seal integrity perspective and maintains the product sterility within the package.In the event that the sealing process creates this glue-like substance defect on the retainer, this defect would be even more noticeable by the or staff once the inner blister was opened.Per ifu 4350, ¿the packaging of all sterile products should be inspected for flaws in the sterile barrier before opening.In the presence of such a flaw, the product must be assumed nonsterile.¿.
 
Event Description
The customer reported that when they opened up the poly liner they noticed a sticky residue under between the paper layer and the outer plastic carton which looks like glue from the paper layer.They opened up a total of 4 liners with the glue residue and completed the case using a 5th liner.There was 5- 10 mins delay while new packages were opened.
 
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Brand Name
TRIDENT 10° X3 INSERT 32MM ID
Type of Device
TRIDENT 10° X3 INSERT 32MM ID
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8050731
MDR Text Key126530277
Report Number0002249697-2018-03657
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327039856
UDI-Public07613327039856
Combination Product (y/n)N
PMA/PMN Number
K033716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Catalogue Number623-10-32E
Device Lot Number6V6WRK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2018
Initial Date Manufacturer Received 10/11/2018
Initial Date FDA Received11/08/2018
Supplement Dates Manufacturer Received12/17/2018
Supplement Dates FDA Received01/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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