MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE ARTHRODESIS NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/01/2005

Event Type  Death  

Manufacturer Narrative

The reported event that a t2 ankle arthrodesis nail was alleged of adverse impact on patient could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Based on the available information, no relation could be established between the device and the reported event.If device is returned or any further information is provided, the investigation report will be reassessed.Device evaluated by mfr: device disposition is unknown.

Event Description

The manufacturer became aware of a study from ¿university of (b)(6) school of medicine, (b)(6)¿ which was published in may-2015.The title of this study is ¿tibiotalocalcaneal arthrodesis using retrograde intramedullary nail fixation: comparison of patients with and without diabetes mellitus¿ and is associated with the stryker t2 ankle arthrodesis nail.Within that publication, post-operative complications/ adverse events were reported, which occurred between 1-jan-2005 until 30-jun-2013.It was not possible to ascertain specific device details from the report; a review of the complaint handling database, however, revealed that the event has not been reported by the hospital or by the author of the publication.Therefore, 68 complaint was initiated retrospectively for the different adverse event mentioned in the report.This product inquiry addresses patient death due to myocardial infarction.The study states: ¿one patient died of a myocardial infarction 10 weeks postoperatively.¿.

• Brand Name: UNKNOWN T2 ANKLE ARTHRODESIS NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8621425
• MDR Text Key: 145433761
• Report Number: 0009610622-2019-00254
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2019
• 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): Death