MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DUAL CUT SAGITTAL BLADE (25 X 1.27 X 100MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 4125127100

Device Problem Break (1069)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 03/22/2017

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device not returned to manufacturer.

Event Description

It was reported that during a total knee procedure, the blade broke at the mount.It was also reported that a blade fragment was found in the patient during a pacu (post anaesthetic care unit) x-ray.It was further reported that the patient went back into surgery on the same day to remove the broken fragment.

Manufacturer Narrative

The quality investigation is complete.

Event Description

It was reported that during a total knee procedure, the blade broke at the mount.It was also reported that a blade fragment was found in the patient during a pacu (post anaesthetic care unit) x-ray.It was further reported that the patient went back into surgery on the same day to remove the broken fragment.

• Brand Name: DUAL CUT SAGITTAL BLADE (25 X 1.27 X 100MM)
• 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: 6515237
• MDR Text Key: 73455949
• Report Number: 0001811755-2017-00876
• Device Sequence Number: 1
• Product Code: GFA
• 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: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4125127100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other