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

Catalog Number UNK_KIE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 02/01/2013

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of a study from (b)(6).The study was published on 26 jun 2017, within that publication, 17 cases involving t2 tibial nail & condylar bolts were reported, which were found to be off-label.The study states, ¿the present report describes the short and intermediate term results of treatment of bicondylar tibial plateau fractures with use of this new technique.[¿] the treatment of bicondylar fractures of the tibial plateau with intramedullary nailing and a condylar bolt or bolts via the suprapatellar approach requires good experience with intramedullary nailing.Therefore, adequate training is required before the adoption of this technique.¿ 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 17 complaints were initiated retrospectively for the off-label use mentioned in the report.This product inquiry addresses refixation due to unsatisfactory reduction of the articular surface.The study states, ¿in 1 patient (case 8), refixation of the fracture was necessary because of unsatisfactory reduction of the articular surface, as shown on radiographs made 5 days after the initial operation.¿.

• Brand Name: UNKNOWN T2 TIBIAL 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 ; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242-32 ; 43487020
• MDR Report Key: 8098827
• MDR Text Key: 128193904
• Report Number: 0009610622-2018-01482
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2018
• 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: 10/31/2018
• 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