MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DUAL CUT SAGITTAL BLADE (18X1.27X100MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 4118127100

Device Problem Break (1069)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 01/11/2017

Event Type  Injury  

Manufacturer Narrative

Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a total knee arthroplasty procedure, two blades broke.It was also reported that the first blade that broke was a reprocessed blade and the surgeon removed the fragment from the patient.It was further reported that the second blade broke at the cutting end, an x-ray was taken which confirmed the fragment was not in the patient¿s body.It was also reported there were no delays and no adverse consequences as a result of this event and the procedure was completed successfully.This report is for the first blade that broke.

Manufacturer Narrative

Investigation results indicate that the blade was reprocessed.The label of the device contains the symbol denoting "single use only" the ifus for handpieces associated with this device contains the following warning: "do not reuse, reprocess, or repackage single use cutting accessories.All cutting accessories are intended for a single use only.Reuse may create a serious risk of contamination and lead to infection or cross-infection.Reprocessing may compromise the structural integrity of the cutting accessory and result in fragmentation during use.".

Event Description

It was reported that during a total knee arthroplasty procedure, two blades broke.It was also reported that the first blade that broke was a reprocessed blade and the surgeon removed the fragment from the patient.It was further reported that the second blade broke at the cutting end, an x-ray was taken which confirmed the fragment was not in the patient¿s body.It was also reported there were no delays and no adverse consequences as a result of this event and the procedure was completed successfully.This report is for the first blade that broke.

• Brand Name: DUAL CUT SAGITTAL BLADE (18X1.27X100MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 6331484
• MDR Text Key: 67460958
• Report Number: 0001811755-2017-00589
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540216892
• UDI-Public: (01)04546540216892
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4118127100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other