MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 14MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 09390114

Device Problems Crack (1135); Difficult to Advance (2920); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was discarded.Additional information was requested and if it becomes available will be submitted in a supplemental report.Discarded by customer.

Event Description

The hospital has reported following to sales rep and customer service malmo; when inserting the plug, they experienced that something cracked.They pulled out/extracted the plug again and could see that there was a crack horizontally on the plug.It was a bit difficult to remove the plug from the introducer.The plug is not longer available since the customer has discarded both implant and box.

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 hospital has reported following to sales rep and customer service (b)(4) when inserting the plug, they experienced that something cracked.They pulled out/extracted the plug again and could see that there was a crack horizontally on the plug.It was a bit difficult to remove the plug from the introducer.The plug is not longer avaliable since the customer has discarded both implant and box.

• Brand Name: EXETER 2.5 I M PLUG 14MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick 00000
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5110513
• MDR Text Key: 27145721
• Report Number: 0002249697-2015-03185
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K980843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: 09390114
• Device Lot Number: L8278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• 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