MAUDE Adverse Event Report: STRYKER GMBH ENDOTRAC EPF/EGR STERILE TRIANGLE BLADE; ARTHROSCOPE

Catalog Number 3054

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

Blade was attached to the blade handle.When the surgeon inserted it into the cannula and began to cut the blade broke.A second blade was opened, the steps repeated, and it broke as well.A third blade from a different lot was then used and performed as intended.

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

Blade was attached to the blade handle.When the surgeon inserted it into the cannula and began to cut the blade broke.A second blade was opened, the steps repeated, and it broke as well.A third blade from a different lot was then used and performed as intended.

• Brand Name: ENDOTRAC EPF/EGR STERILE TRIANGLE BLADE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6185579
• MDR Text Key: 63078018
• Report Number: 0008031020-2016-00622
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940230
• 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: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 3054
• Device Lot Number: MBSL610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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