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

Catalog Number UNK_KIE

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of a study from medical university of (b)(6).The study was published on july 2017, within that publication, 11 cases involving t2 ankle arthrodesis nail, or t2 tibial nail were reported, which were found to be off-label.The study states, ¿the purpose of this study was to present a case series of patients undergoing various techniques of joint fusion after bone reconstruction and deformity correction as a salvage procedure.The study should help trauma surgeons making decisions in limb salvage and deformity correction in complex lower leg and foot injuries by presenting options and treatment strategies.¿ it was not possible to ascertain specific device from the report, a review of the complaint handling database, however, revealed that the events have not been reported previously, therefore 11 complaints were initiated retrospectively for the off-label use and subsequent adverse events mentioned in the report.This product inquiry addresses delayed union of arthrodesis.1 out of 2 cases.

• Brand Name: UNKNOWN T2 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8105648
• MDR Text Key: 128403832
• Report Number: 0009610622-2018-01494
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/27/2018
• 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