• 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 TRIATHLON FIX. PEG 2 PER PK PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

  • 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 TRIATHLON FIX. PEG 2 PER PK PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5575X000
Device Problems Contamination of Device Ingredient or Reagent (2901); Device Disinfection Or Sterilization Issue (2909); Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 03/14/2016
Event Type  Malfunction  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was disposed of by the hospital and was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
Event Description

Hair was sterilized in box.

 
Manufacturer Narrative

Reported event: an event regarding a hair trapped in the seal of an inner blister pack involving a triathlon fixation peg pack was reported. The event was confirmed. Method and results: device evaluation and results: visual inspection confirmed that there is a dark hair visible within the seal area, travelling to the outside of the pack. The presence of the hair trapped in the inner blister seal is confirmed. Medical records received and evaluation: not performed as this event relates to a packaging issue. Device history review: the device was manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events for the lot referenced. Conclusions: the investigation concluded that the presence of a hair in the seal of the blister pack may have been caused in the packaging department where the operator may have failed to detect the foreign matter.

 
Event Description

Hair was sterilized in box.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRIATHLON FIX. PEG 2 PER PK
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5555833
MDR Text Key42150726
Report Number0002249697-2016-01114
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2020
Device Catalogue Number5575X000
Device LOT NumberAJJ9Y
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/15/2015
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: 04/07/2016 Patient Sequence Number: 1
-
-