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

Catalog Number UNK_KIE

Device Problems Failure to Align (2522); Material Deformation (2976)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2006

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 (b)(6) hospital, (b)(6).The study was published on 5 may 2011, within that publication, 14 cases involving supracondylar femoral nail(scn) & t2 tibial nail were reported, which were found to be off-label.The study states, ¿to overcome these problems and improve outcomes, certain modifications to the standard operative technique have been proposed, such as the use of blocking screws, additional buttress plate, different patient positioning, and extended parapatellar or retro patellar approaches.According to this guideline, the entry portal of the nail on the coronal level must be lateral or medial, depending on the side where the fracture approximates most the articular surface of the proximal tibia on the anteroposterior (ap) view.¿ it was not possible to ascertain specific device or patient information from the report, a review of the complaint handling database, however, revealed that the events have not been reported previously, therefore 14 complaints were initiated retrospectively for the off-label use mentioned in the report.This product inquiry addresses the excessive varus/ revision nailing.The report states, ¿there was also a case (case 11) where the preoperative assessment led to a wrong decision for the entry portal location, leading to unacceptable fracture alignment (158 of varus deformity).The patient was re-operated few days later when a new mid-line entry portal changed the trajectory of the nail and resulted in the restoration of leg alignment.¿.

• 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 ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8098826
• MDR Text Key: 128186737
• Report Number: 0009610622-2018-01481
• 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