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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MIS MODULAR DISTAL CAPTURE; INSTRUMENT
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STRYKER ORTHOPAEDICS-MAHWAH MIS MODULAR DISTAL CAPTURE; INSTRUMENT Back to Search Results
Catalog Number 6541-5-723
Device Problems Sticking (1597); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2014
Event Type  malfunction  
Event Description
It was reported that during a primary surgery while the surgeon was cutting the distal femur, the nail and the locking mechanism fell out of the capture so the capture is now stuck on the cutting block.The surgery was completed successfully.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
An event regarding subcomponent dissociation involving a triathlon modular distal capture was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection confirmed the event.Medical records received and evaluation: not performed because no records were provided for review.Device history review: all devices accepted into final stock met specification.Complaint history review: there have been no other events for the reported lot.Conclusions: the reported event was confirmed.A material analysis performed for the same product and issue found no evidence on the pins to indicate press-fit conditions.Examination with the material analysis team confirmed the subject to be within the scope of an nc that was raised with the supplier to address the observed nonconformance.
 
Event Description
It was reported that during a primary surgery while the surgeon was cutting the distal femur, the nail and the locking mechanism fell out of the capture so the capture is now stuck on the cutting block.The surgery was completed successfully.
 
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Brand Name
MIS MODULAR DISTAL CAPTURE
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 Key3781220
MDR Text Key4357872
Report Number0002249697-2014-01669
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,health professional,oth
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6541-5-723
Device Lot NumberAF4C07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received10/06/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/08/2009
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;
Patient Age72 YR
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