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 Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

During primary surgery, sales rep gave package to nurse and upon the nurse reviewing the package to open, she noticed there was only 1 peg in the box.The box was never opened.It was noticed fully packaged.A backup was available and the surgery was completed.

Manufacturer Narrative

An event regarding missing peg involving a triathlon fixation peg was reported.The event was confirmed by returned product.Method & results: device evaluation and results: visual inspection of the returned unit confirmed the reported event that there is only one peg within the blister pack when as per the packaging labeling there should be two pegs.Medical records received and evaluation: not performed as no medical records were provided.A back up product was available.No adverse consequences to the patient were reported.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 omission of the peg may have occurred in the packaging department.An internal capa determined human error was the root cause of the event.No further investigation is possible at this time.

Event Description

During primary surgery, sales rep gave package to nurse and upon the nurse reviewing the package to open, she noticed there was only 1 peg in the box.The box was never opened.It was noticed fully packaged.A backup was available and the surgery was completed.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5483212
• MDR Text Key: 40033059
• Report Number: 0002249697-2016-00697
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 5575X000
• Device Lot Number: ART7L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2015
• 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