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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL RESECTION GUIDE LT; INSTRUMENT
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STRYKER ORTHOPAEDICS-MAHWAH TIBIAL RESECTION GUIDE LT; INSTRUMENT Back to Search Results
Catalog Number 6541-2-701
Device Problems Sticking (1597); Failure to Advance (2524); Material Distortion (2977); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/21/2014
Event Type  malfunction  
Event Description
It was reported that during the primary surgery the fluted pin got stuck in the hole of the cutting block.The pin would not go through to engage into the patients bone.Another set of holes were used and the surgery was completed successfully.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
An event regarding a seizing triathlon tibial resection guide was reported.The event was confirmed.Method & results: device evaluation and results: no material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been similar reported events for this lot id.Conclusions: the investigation concluded that material smearing was present in a hole of the tibial resection guide, likely caused by galling between the pin and the guide hole.No material or manufacturing defects were identified.
 
Event Description
It was reported that during the primary surgery the fluted pin got stuck in the hole of the cutting block.The pin would not go through to engage into the patients bone.Another set of holes were used and the surgery was completed successfully.
 
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Brand Name
TIBIAL RESECTION GUIDE LT
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 Key3753447
MDR Text Key4467451
Report Number0002249697-2014-01227
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
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 03/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6541-2-701
Device Lot NumberAFYL00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received08/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2005
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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