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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LEFT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE; INSTRUMENT
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STRYKER ORTHOPAEDICS-MAHWAH LEFT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE; INSTRUMENT Back to Search Results
Catalog Number 2124-1750
Device Problems Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2014
Event Type  malfunction  
Event Description
It was reported that during the primary surgery, when the surgeon went to remove the broach, the surgeon stated that the handle broke.A second broach handle was used to try and remove the broach and it didn't feel like it was fully locking onto the broach however, the broach was able to be removed.
 
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Manufacturer Narrative
The event was confirmed.A review of stryker¿s nc/capa database indicated that an ncr was raised on sep-2009 due to believed to be a design non-conformance, manufacturing non-conformance, or combination of the two.Rasp handles will not close on the rasp trunnion, and/or will jam during attempted closure, bending the flat spring portion of the latching lever assembly.The ncr was initiated to establish root cause and corrective action for what was originally believed to be a design or manufacturing non-conformance.Although the investigation uncovered no non-conformance, the ncr remained open to address improvements in lubrication process documentation used by the manufacturing cell.An ecr updated the inspection guide sheets to show all required lubrication points for the device.Igs revision 9 includes these improvements and was released on oct-2009.The ncr was closed in october, 2010, with the completion of all open actions.No material or manufacturing defects were observed on the device features examined.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were one other similar event for the reported lot.Product surveillance will continue to monitor for trends.
 
Event Description
It was reported that during the primary surgery, when the surgeon went to remove the broach, the surgeon stated that the handle broke.A second broach handle was used to try and remove the broach and it didn't feel like it was fully locking onto the broach however, the broach was able to be removed.
 
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Brand Name
LEFT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE
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
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3666575
MDR Text Key4319773
Report Number0002249697-2014-00660
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123604
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/10/2014
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 Number2124-1750
Device Lot NumberP8M15
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/10/2014
Initial Date FDA Received03/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2013
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;
Patient Age65 YR
Patient Weight91
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