Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 3; IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 3; IMPLANT Back to Search Results
Catalog Number 5521-B-300
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2015
Event Type  malfunction  
Event Description
It was reported that the inner and outer blister/sterility packaging was stuck together.It was reported that upon opening the outer blister, it appeared fused to the inner blister.It was reported that a second implant was opened and used for the surgery.
 
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Manufacturer Narrative
Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Conclusion: visual inspection of the returned indicated the inner tyvek lid had delaminated, leaving a layer stuck to the outer lid and another layer covering the inner blister.It is likely the inner lid was stuck to the outer tyvek lid, causing it to delaminate when the outer lid was peeled back.The root cause was determined to be a known packaging issue.Packaging innovations is aware of this, and has issued a memo.
 
Event Description
It was reported that the inner and outer blister/sterility packaging was stuck together.It was reported that upon opening the outer blister, it appeared fused to the inner blister.It was reported that a second implant was opened and used for the surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRI TS BASEPLATE SIZE 3
Type of Device
IMPLANT
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
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4892683
MDR Text Key6535708
Report Number0002249697-2015-02195
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/09/2015
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 Date03/31/2020
Device Catalogue Number5521-B-300
Device Lot NumberMPHWD
Other Device ID NumberSTERILE LOT# MSHPE09A3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/09/2015
Initial Date FDA Received07/06/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2015
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;
-
-