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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON MIS FULLY CAPTURED 4-IN-1 BLOCK SET PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON MIS FULLY CAPTURED 4-IN-1 BLOCK SET PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number I-K2359CB00
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2017
Event Type  Malfunction  
Manufacturer Narrative

An event regarding alleged "weld failure" involving a specialty triathlon misfully captured 4-in-1 block set was reported. The event was confirmed. Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies. There has been no other event for the lot referenced. The investigation concluded that based on the examination of the material analysis that "the welds of the capture of the specialty mis 4:1 cutting block broke in fatigue. No material or manufacturing defects were observed during this examination. " if additional information becomes available, this investigation will be reopened.

 
Event Description

Sales rep reported, during a right tka the 4 in 1 cutting block blade slot to make posterior cut broke off.

 
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Brand NameSPECIALTY TRIATHLON MIS FULLY CAPTURED 4-IN-1 BLOCK SET
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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
sarah smelko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6444500
MDR Text Key71228993
Report Number0002249697-2017-01072
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberI-K2359CB00
Device LOT NumberF3L6504
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/13/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/09/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/29/2017 Patient Sequence Number: 1
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