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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON FULLY CAPTURED DISTAL RESECTION GUIDE PER FILE K2869; INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON FULLY CAPTURED DISTAL RESECTION GUIDE PER FILE K2869; INSTRUMENT Back to Search Results
Catalog Number I-K2869KF00
Device Problems Difficult to Remove (1528); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/17/2014
Event Type  malfunction  
Event Description
After placing the im distal resection assembly into the femur surgeon's resident (b)(6) started to pin the block to the femur using a wire driver on stryker system 6 power.While driving the pin into the bone it became stuck in the cutting block and was not able to be removed.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
An event regarding pin seizure involving a specialty triathlon guide was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis indicated the pin galled in the guide hole.No material or manufacturing defects were observed on the device features evaluated.-medical records received and evaluation: records were not provided.There is no indication the event is patient related.-device history review: the reported device was manufactured and accepted into final stock with no discrepancies.-complaint history review: there have been no other events for the reported lot id.Conclusions: the investigation concluded that the pin galled and seized in the guide hole.A capa was issued and a design change was implemented to add flutes to the bottom half of the pin.The fluted pins will allow the pin to act as a drill bit and clear any burrs or debris located on the inside surfaces of the cutting blocks/guides.The reported pin is contained within the scope of capa.
 
Event Description
After placing the im distal resection assembly into the femur surgeon's resident (b)(6) started to pin the block to the femur using a wire driver on stryker system 6 power.While driving the pin into the bone it became stuck in the cutting block and was not able to be removed.
 
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Brand Name
SPECIALTY TRIATHLON FULLY CAPTURED DISTAL RESECTION GUIDE PER FILE K2869
Type of Device
INSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3688675
MDR Text Key4291059
Report Number0002249697-2014-00810
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123486
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 02/18/2014
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 Catalogue NumberI-K2869KF00
Device Lot NumberF8W761301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2015
Initial Date FDA Received03/19/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/18/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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