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

Catalog Number	4118127100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.
Event or Problem 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.
Additional 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 or Problem 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)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 6331484
• Report Number: 0001811755-2017-00589
• Device Sequence Number: 16420442
• Product Code: GFA
• UDI-Device Identifier: 04546540216892
• UDI-Public: (01)04546540216892
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 4118127100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other