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 Device Embedded In Tissue or Plaque (3165)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

The customer reported that during a thr procedure involving an exeter cemented stem, the exeter plug allegedly split on insertion.There was a delay to surgery of 5 minutes while the surgeon tried to retrieve the plug.Half of the plug was left in the patient and an additional plug was used to complete the procedure.

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 will be submitted in a supplemental report.Product cannot be decontaminated.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: not performed as no medical records were provided.-device history review: dhr review was satisfactory.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: 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.A capa trend analysis was conducted for the reported failure mode and concluded that fracture of exeter bone plugs may result from factors such as errors made during use or design factors.No further investigation for this event is possible at this time as the device was not received by stryker orthopaedics.If the device becomes available, this investigation will be reopened.

Event Description

The customer reported that during a thr procedure involving an exeter cemented stem, the exeter plug allegedly split on insertion.There was a delay to surgery of 5 minutes while the surgeon tried to retrieve the plug.Half of the plug was left in the patient and an additional plug was used to complete the procedure.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4813065
• MDR Text Key: 5917777
• Report Number: 0002249697-2015-01780
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

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: 10/01/2019
• Device Catalogue Number: 09390116
• Device Lot Number: L7248
• Other Device ID Number: STERILE LOT# QA1S4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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