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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; Physical Resistance/Sticking
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. There has been 1 other similar event for the lot referenced. 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.

 
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Brand NameTRIDENT 10° X3 INSERT 32MM ID
Type of DeviceTRIDENT 10° X3 INSERT 32MM ID
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
juana hiciano
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key8050977
Report Number0002249697-2018-03659
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number623-10-32E
Device LOT Number6V6WRK
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/11/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/08/2018 Patient Sequence Number: 1
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