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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 Break (1069); Material Fragmentation (1261); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2015
Event Type  malfunction  
Event Description
A stryker sales rep reported that a second similar incident happened.The incident was that during surgery the introducer was removed and the part of the plug was left inside the introducer.It was further reported by the nurse that during the surgery that took place on (b)(6) 2015 one bone plug broke, code 09390114, lot l8270.It is unknown which introducer of the two returned have been used during the surgery.(both introducers were the same catalog number and lot code.) no other information were given regarding the outcome of the surgery for the patient.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
An event regarding a fractured device involving an exeter bone plug was reported.The event was not confirmed as the returned device cannot be confirmed as the subject device.Method & results: -device evaluation and results: material analysis was performed and indicated that the bone plug failed in overload.The exact location of the fracture origin was not possible to be determined due post-fracture degradation of the polymer material.No material or manufacturing defects were observed on the device features examined.It is noted that the returned device cannot be confirmed as the subject device.-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 events for the reported lot.Conclusions: based on material analysis that was performed on the returned segment of the bone plug, the bone plug failed in overload.The exact location of the fracture origin was not possible to be determined due post-fracture degradation of the polymer material.No material or manufacturing defects were observed on the device features examined.It is noted that the returned device cannot be confirmed as the subject device.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 insufficient information was received.If additional information becomes available, this investigation will be reopened.
 
Event Description
A stryker sales rep reported that a second similar incident happened.The incident was that during surgery the introducer was removed and the part of the plug was left inside the introducer.It was further reported by the nurse that during the surgery that took place on (b)(6) 2015 one bone plug broke, code 09390114, lot l8270.It is unknown which introducer of the two returned have been used during the surgery.(both introducers were the same catalog number and lot code.) no other information were given regarding the outcome of the surgery for 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 (MDR)
raheen business park
limerick NA
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4808666
MDR Text Key5929182
Report Number0002249697-2015-01769
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,health professional,oth
Reporter Occupation Other
Type of Report Initial
Report Date 05/06/2015
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 Date02/28/2020
Device Catalogue Number09390114
Device Lot NumberL8270
Other Device ID NumberSTER. LOT T215A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/06/2015
Initial Date FDA Received06/01/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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