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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO HUDSON/MODIFIED TRINKLE ATTACH; INSTRUMENT, SURGICAL ORTHOPEDIC
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STRYKER INSTRUMENTS-KALAMAZOO HUDSON/MODIFIED TRINKLE ATTACH; INSTRUMENT, SURGICAL ORTHOPEDIC Back to Search Results
Catalog Number 6203135000
Device Problem Unstable (1667)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/31/2014
Event Type  malfunction  
Event Description
It was reported that the hudson/modified trinkle attachment wobbled during use in a procedure resulting in the hole being cut larger than intended.The procedure was completed successfully with a back up device.There were no patient or user injuries, and no adverse consequences.
 
Manufacturer Narrative
Device not available for evaluation.
 
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Brand Name
HUDSON/MODIFIED TRINKLE ATTACH
Type of Device
INSTRUMENT, SURGICAL ORTHOPEDIC
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3773922
MDR Text Key4357632
Report Number0001811755-2014-01515
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6203135000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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