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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 have been no other similar events 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 Key8052839
Report Number0002249697-2018-03660
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 NumberDJ7RYV
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? No
Date Device Manufactured12/04/2017
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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