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

Catalog Number 0940023000

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

A partial blade was returned for evaluation.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during service conducted at the manufacturer a broken piece of a blade was found inside the handpiece castcutter.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

Manufacturer Narrative

Investigation results concluded that misloading of the device was a contributing factor to the fracture of the blade.The ifu for devices associated with the blade state the following "before operating the equipment, always make sure the blade is securely installed and the blade retention screw is tight.An improperly tightened screw may come loose and cause the blade to fracture".

Event Description

It was reported that during service conducted at the manufacturer a broken piece of a blade was found inside the handpiece castcutter.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

• Brand Name: ION NITRIDED 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 5857237
• MDR Text Key: 51497676
• Report Number: 0001811755-2016-01753
• Device Sequence Number: 1
• Product Code: LGH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0940023000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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