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 TRIDENT 0° INSERT TRIAL 32MM; INSTRUMENT
  • 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 TRIDENT 0° INSERT TRIAL 32MM; INSTRUMENT Back to Search Results
Catalog Number 2200-32E
Device Problems Break (1069); Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2014
Event Type  malfunction  
Event Description
A 2200-32e 32mm neutral insert trial broke when removing from the patient.Plastic around the locking screw broke cleanly disconnecting the screw from the trial insert.No replacement device was needed.
 
Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.
 
Manufacturer Narrative
Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot visual inspection: the visible brown discoloration in that region indicates the part was breaking over time.No material or manufacturing defects were observed on the surfaces examined.A material analysis was performed, concluding: the plastic broke in the region that supports the locking screw.The fracture occurred over time until the final fracture experienced in this usage.No material or manufacturing defects were observed on the surfaces examined.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.
 
Event Description
(b)(4) 32mm neutral insert trial broke when removing from the patient.Plastic around the locking screw broke cleanly disconnecting the screw from the trial insert.No replacement device was needed.
 
Manufacturer Narrative
The investigation determined the plastic broke in the region that supports the locking screw.The fracture occurred over time until the final fracture experienced in this usage.No material or manufacturing defects were observed on the surfaces examined.
 
Event Description
A 2200-32e 32mm neutral insert trial broke when removing from the patient.Plastic around the locking screw broke cleanly disconnecting the screw from the trial insert.No replacement device was needed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIDENT 0° INSERT TRIAL 32MM
Type of Device
INSTRUMENT
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 Key4233269
MDR Text Key4998917
Report Number0002249697-2014-04205
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 10/15/2014
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 Catalogue Number2200-32E
Device Lot Number22690101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/21/2015
Initial Date FDA Received11/06/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received07/10/2015
07/22/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
Patient Weight86
-
-