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

Catalog Number UNK_KIE

Device Problem Defective Component (2292)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Date 01/01/2005

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device disposition is unknown.

Event Description

The manufacturer became aware of a study from ¿university of pittsburgh school of medicine, pittsburgh¿ 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 below-the-knee amputation because of symptomatic nonunion with hardware failure and chronic pain.2 out of 2 cases.The study states: ¿of the 5 patients in our series who subsequently required below-the-knee amputation, 2 did so because of symptomatic nonunion with hardware failure and chronic pain and 3 because of persistent deep infection.¿.

• Brand Name: 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: 8642250
• MDR Text Key: 146207721
• Report Number: 0009610622-2019-00342
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• 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): Disability