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

Catalog Number UNK_KIE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Impaired Healing (2378)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a pmcf from (b)(6).The title of this report is ¿a retrospective data collection of the treatment of femur fractures with the t2 femoral nailing system¿ which is associated with the stryker ¿t2 femoral nailing¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 1/2014 to 12/2018.It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 42 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses delayed healing followed by revision with new nail.The report states: ¿a (b)(6) year old caucasian male (#48) with an open femur fracture was treated with t2 femur nail.After 4 months delayed healing was diagnosed.The nail was removed and a new t2 femur nail was inserted.Consolidation progressed and complete consolidation was radiologically confirmed after two years.¿.

• Brand Name: UNKNOWN T2 FEMUR NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10044344
• MDR Text Key: 191127496
• Report Number: 0008031020-2020-01447
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: DE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• 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: 04/14/2020
• 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
• Patient Age: 19 YR