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

Catalog Number UNK_KIE

Device Problems Loss of or Failure to Bond (1068); Unintended Movement (3026)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of a post market clinical follow-up (pmcf) from inova fairfax medical campus (ifmc).The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of tibial fractures with the t2 tibial nailing system¿ which was published in june 2018 and is associated with the t2 tibial nailing system.Within that publication, postoperative complications/ adverse events were reported, which occurred between november 2012 to september 2017.It was not possible to ascertain specific device or patient information from the article, 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 66 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses screw backout.1 out of 2 cases.The pmcfr states: ¿subject a.9 was a (b)(6) year old african american male, with a left open (gustillo iiia) tibia fracture after being a pedestrian struck by a moped.Subject has a history significant for current tobacco use and diabetes.Other multi-trauma injuries, however no additional orthopaedic injuries.Subject underwent an irrigation and debridement, tendon repair and a t2 tibial nail.This nail proximal fixation was in the transverse (medial to lateral) and oblique modes with 2 distal screws in 1 plane.Subject was discharged on pod # 2 to home, non-weightbearing.Throughout the postoperative period, subject had delayed union, malunion and screw backout.At a follow-up appointment, pod #319, radiographs demonstrated interval backing out of one of the distal interlock screws, stable alignment and construct.It was recommended to subject to return for a hardware removal, however the subject declined.Subject 5 months later came in for a follow-up for an exposed screw distally with wound breakdown.Due to the amount of exposure, the screw was removed in the office under sterile conditions.Subject eventually went on to have bony consolidation.¿.

• Brand Name: UNK T2 TIBIA 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: melissa guattery ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7703928
• MDR Text Key: 114538731
• Report Number: 0009610622-2018-00330
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• 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
• Patient Age: 54 YR