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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 14MM; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 14MM; IMPLANT Back to Search Results
Catalog Number 09390114
Device Problems Material Fragmentation (1261); Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2014
Event Type  malfunction  
Event Description
The surgeon reported via the clinical support specialist, that whilst implanting the exeter intramedullary plug, the plug broke into several pieces.The surgeon reported that he was able to successfully remove all debris from the wound site and attempted to use an identical replacement device with the same lot number.The surgeon reported that the same issue occurred.The surgeon reported that a third device was therefore used, again, with the same lot number, but once again he experienced the same issue with the device breaking into several pieces.The surgeon reported that he used a fourth device from a different lot number which he was able to implant successfully with no issues.The surgeon reported that no debris remained in the patient from the previous broken plugs.The surgeon reported that the event resulted in approximately a 10 minute delay to surgery time and that there were no adverse consequences to the patient.
 
Manufacturer Narrative
An evaluation of the device cannot be performed as the device was discarded and was not returned to the manufacturer.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.
 
Manufacturer Narrative
An event regarding a fractured device involving exeter bone plugs was not confirmed.-device evaluation and results: not performed as no devices were 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 one other similar event for the reported lot.The cause of this event could not be determined as the item was not returned for evaluation.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 surgeon reported via the clinical support specialist, that whilst implanting the exeter intramedullary plug, the plug broke into several pieces.The surgeon reported that he was able to successfully remove all debris from the wound site and attempted to use an identical replacement device with the same lot number.The surgeon reported that the same issue occurred.The surgeon reported that a third device was therefore used, again, with the same lot number, but once again he experienced the same issue with the device breaking into several pieces.The surgeon reported that he used a fourth device from a different lot number which he was able to implant successfully with no issues.The surgeon reported that no debris remained in the patient from the previous broken plugs.The surgeon reported that the event resulted in approximately a 10 minute delay to surgery time and that there were no adverse consequences to the patient.
 
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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
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3761840
MDR Text Key14877453
Report Number0002249697-2014-01295
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K980843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/25/2014
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 Date01/30/2019
Device Catalogue Number09390114
Device Lot NumberL6767
Other Device ID NumberSTERILE LOT 211S8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/15/2014
Initial Date FDA Received04/21/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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