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 10/06/2014

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

It was reported that the surgeon had a 3054 triangle blade break during an endoscopic plantar fasciitis procedure.

Manufacturer Narrative

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

Event Description

It was reported that the surgeon had a 3054 triangle blade break during an endoscopic plantar fasciitis procedure.

• 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: 6185582
• MDR Text Key: 63109359
• Report Number: 0008031020-2016-00627
• 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