MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 14MM; IMPLANT

Catalog Number 09390114

Device Problem Material Fragmentation (1261)

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

Event Date 03/27/2015

Event Type  malfunction  

Event Description

The customer reported that the 14mm exeter plug broke during implantation.The customer further reported that the pieces could not be retrieved and are in still inside the patient.The customer also reported that some of the plug remained stuck to the inserter.A second plug was inserted over the broken one and the surgeon had to take a second inserter to accomplish this.The case was completed successfully.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Device remains implanted.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was reported.The event was confirmed by x-ray.Method & results: the device was not returned for evaluation.Review of the x-rays provided indicated that the cement plug fracture was related to cementation technique with a circular plug in an oval shaped femoral canal which causes less than perfect fit with a local overload condition at the small side of the oval while still allowing cement leakage along the big side of the oval.Problem aggravated by femoral dysplasia and/or young age anatomy of proximal femur.Dhr review was satisfactory.Complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: the medical review indicates that the cement plug fracture was related to cementation technique with a circular plug in an oval shaped femoral canal which causes less than perfect fit with a local overload condition at the small side of the oval.The problem was aggravated by femoral dysplasia and/or young age anatomy of proximal femur.However, 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 the 14mm exeter plug broke during implantation.The customer further reported that the pieces could not be retrieved and are in still inside the patient.The customer also reported that some of the plug remained stuck to the inserter.A second plug was inserted over the broken one and the surgeon had to take a second inserter to accomplish this.The case was completed successfully.

• Brand Name: EXETER 2.5 I M PLUG 14MM
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4714561
• MDR Text Key: 5667989
• Report Number: 0002249697-2015-01299
• 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: 03/27/2015

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: 02/28/2019
• Device Catalogue Number: 09390114
• Device Lot Number: L8268
• Other Device ID Number: STER. LOT T21SC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 04/21/2015
• 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: 02/24/2015
• 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
• Patient Age: 52 YR