MAUDE Adverse Event Report: STRYKER GMBH ENDOTRAC EPF/EGR STERILE HOOK BLADE; BUTTON/SUTURE

Catalog Number 3055

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2014

Event Type  malfunction  

Manufacturer Narrative

On october 14, 2016, howmedica osteonics corp., a wholly owned subsidiary of stryker corporation (collectively ¿stryker¿), acquired substantially all of the assets of restore surgical llc, d/b/a instratek (¿restore¿) (the ¿transaction¿).This mdr is submitted by stryker (b)(4) as a result of a retrospective lookback resulting from the transaction.The reported devices were manufactured and distributed by restore prior to the closing of the transaction.Stryker became legal manufacturer of this product on october 14, 2016 and has taken the responsibility for medical device reporting.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device is not available to stryker.

Event Description

We were doing a epf and had made one cut and had just placed the blade in the tissue to start the second cut and the blade broke in the handle at the notch just like the other one broke.There was no injury to the patient and we opened another blade and finished the procedure.

Manufacturer Narrative

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

Event Description

We were doing an epf and had made one cut and had just placed the blade in the tissue to start the second cut and the blade broke in the handle at the notch just like the other one broke.There was no injury to the patient and we opened another blade and finished the procedure.

• Brand Name: ENDOTRAC EPF/EGR STERILE HOOK BLADE
• Type of Device: BUTTON/SUTURE
• 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: 6185585
• MDR Text Key: 63187110
• Report Number: 0008031020-2016-00624
• 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: 08/31/2018
• Device Catalogue Number: 3055
• Device Lot Number: MBT L070 46
• 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: 08/01/2013
• 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