MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 16MM; IMPLANT

Catalog Number 09390116

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

Sales rep informed that item ref 09390114 was broken into many pieces when implanted.Also item ref 09390116 was broken into many pieces when implanted.There was 20 minutes delay during the operation because the broken pieces had to be removed twice.Operation was completed with competitor's product.

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.Not returned.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was reported.The event was not confirmed.Device evaluation could not be 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 was satisfactory.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.

Event Description

Sales rep informed that item (b)(4) was broken into many pieces when implanted.Also item (b)(4) was broken into many pieces when implanted.There was 20 minutes delay during the operation because the broken pieces had to be removed twice.Operation was completed with competitor's product.

• Brand Name: EXETER 2.5 I M PLUG 16MM
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3929242
• MDR Text Key: 4665336
• Report Number: 0002249697-2014-02692
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K980843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2014

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: 10/31/2018
• Device Catalogue Number: 09390116
• Device Lot Number: L6578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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