MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 10MM; IMPLANT

Catalog Number 09390110

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2014

Event Type  malfunction  

Event Description

The sales rep., reported on behalf of the surgeon that an intramedullary plug broke as the surgeon was inserting it.The surgeon reported that the plug felt brittle and broke into pieces.The surgeon further reported that all the broken parts of the plug were identified, retrieved and have been discarded.The surgeon reported that the surgery was delayed by approximately 5 minutes whilst replacement devices were sought.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report.Discarded.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was not confirmed.Device evaluation and results: not performed as no device was returned.Medical records received and evaluation: not performed and not relevant to this investigation, the reported product was not implanted.Device history review: dhr review was satisfactory.Complaint history review: a complaint history review confirmed no other similar events for the reported lot.The exact cause of the event could not be determined with the available information.Return of the reported device for evaluation is required to complete the investigation for determining the root cause.No further investigation for this event is possible at this time as the device was not received by stryker orthopaedics.

Event Description

The sales rep., reported on behalf of the surgeon that an intramedullary plug broke as the surgeon was inserting it.The surgeon reported that the plug felt brittle and broke into pieces.The surgeon further reported that all the broken parts of the plug were identified, retrieved and have been discarded.The surgeon reported that the surgery was delayed by approximately 5 minutes whilst replacement devices were sought.

• Brand Name: EXETER 2.5 I M PLUG 10MM
• Type of Device: IMPLANT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3631478
• MDR Text Key: 4179365
• Report Number: 0002249697-2014-00426
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K980843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/22/2014

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 Expiration Date: 09/30/2018
• Device Catalogue Number: 09390110
• Device Lot Number: L6500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 02/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2013
• 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