MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #7R; IMPLANT

Catalog Number 5517F702

Device Problems Shipping Damage or Problem (1570); Tear, Rip or Hole in Device Packaging (2385); Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2015

Event Type  malfunction  

Event Description

Loan size 7 femoral triathlon implant opened by circulating nurse.Outer package noted to be cracked.Inner deemed not sterile by surgeon and scrub nurse.Additional loan item available and used.

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed.Method & results: device evaluation and results: based on the visual inspection of the returned packaging it appears that this component packaging was subjected to excessive/inappropriate handling whereby the carton may have been compressed and/or dropped from a height causing the flange of the outer blister to fracture.Medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the opening packaging.No further investigation for this event is required at this time.

Event Description

Loan size 7 femoral triathlon implant opened by circulating nurse.Outer package noted to be cracked.Inner deemed not sterile by surgeon and scrub nurse.Additional loan item available and used.

• Brand Name: TRIATHLON P/A CR BEADED #7R
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK (MDR); raheen business park; limerick NA
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4851538
• MDR Text Key: 18663450
• Report Number: 0002249697-2015-01956
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2015

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 Date: 03/31/2020
• Device Catalogue Number: 5517F702
• Device Lot Number: EMR3P
• Other Device ID Number: STERILE LOT: T3126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2015
• Initial Date FDA Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2015
• 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