MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STAINLESS STEEL BLADE; INSTRUMENT, CAST REMOVAL, AC-POWERED

Catalog Number 0840040250

Device Problems Break (1069); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

It was reported that the blade broke after being used 10 times.There were no adverse consequences or surgical delay reported as a result of this event.

Event Description

It was reported initially reported that the blade broke after being used 10 times.It was subsequently reported that the blade was blunt.There were no adverse consequences or surgical delay reported as a result of this event.

Manufacturer Narrative

The device return has been requested.A follow up report will be filed once the quality investigation is complete.Device not yet made available for return.

Manufacturer Narrative

The cast cutter blade associated with this event was returned to the manufacturer for evaluation.It was visually confirmed there was no excessive wear on the teeth that all teeth were intact.Follow up information received confirmed that the cast cutter was being used to cut synthetic material.The ifu (instructions for use) for the cast cutter blade cautions the user that the stainless steel cast cutter blades are not recommended for use with synthetic material.The use of this cast cutter blade with synthetic material may have made the blade appear to be dull when in use with such cutting material.

• Brand Name: STAINLESS STEEL BLADE
• Type of Device: INSTRUMENT, CAST REMOVAL, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: dervillia murphy ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 4111802
• MDR Text Key: 4703300
• Report Number: 0001811755-2014-03342
• Device Sequence Number: 1
• Product Code: LGH
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0840040250
• Device Lot Number: 14168017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1