MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FIX. PEG 2 PER PK; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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.

• Brand Name: TRIATHLON FIX. PEG 2 PER PK
• Type of Device: PROSTHESIS, 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 Key: 5555833
• MDR Text Key: 42150726
• Report Number: 0002249697-2016-01114
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• 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 Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 5575X000
• Device Lot Number: AJJ9Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other