MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LEFT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE; INSTRUMENT

Catalog Number 2124-1750

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2013

Event Type  malfunction  

Event Description

It was reported that during the tha, when the surgeon was rasping with the broach handle, the lever of handle constantly loosened.

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 belirved 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.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 no similar events for the reported lot.No material or manufacturing defects were observed on the device features examined.

Event Description

It was reported that during the tha, when the surgeon was rasping with the broach handle, the lever of handle constantly loosened.

• 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 Key: 3603938
• MDR Text Key: 4064182
• Report Number: 0002249697-2014-00264
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• 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: 01/08/2014

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 Number: 2124-1750
• Device Lot Number: P6C42
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 02/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other