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

Catalog Number UNK_KIE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Date 03/01/2005

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 evaluated by mfr: device disposition is unknown.

Event Description

The manufacturer became aware of a study from ¿university hospital (b)(6)¿ which was published in january 2011.The title of this study is ¿short-term outcome of retrograde tibiotalocalcaneal arthrodesis with a curved intramedullary nail¿ and is associated with the t2 ankle arthrodesis nail.Within that publication, post-operative complications/ adverse events were reported which occurred between march 2005 and april 2008.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, 23 complaint were initiated retrospectively for the different adverse event mentioned in the report.This product inquiry addresses soft-tissue irritation.3 out of 3 cases.The study states: ¿in three cases the nail had caused soft-tissue irritation.Once sound union had been ascertained, the calcaneal screw was removed in two of these patients, while in the third patient the entire nail was removed.¿.

• 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: 8642367
• MDR Text Key: 146218027
• Report Number: 0009610622-2019-00374
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• 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?: Yes
• 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: 05/13/2019
• 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): Required Intervention