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

Catalog Number UNK_KIE

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device disposition is unknown.

Event Description

The manufacturer became aware of a study from eberhard karls university of tübingen, germany.The title of this report is ¿exchange reamed nailing compared to augmentation compression plating leaving the inserted nail in situ in the treatment of aseptic tibial non-union: a two centre study¿ which was published on 15 may 2013 and is associated with the t2 tibia nail.Within that report, post-operative complications/ adverse events were reported.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 6 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses hypertrophic aseptic non-union after un-reamed nailing.1 out of 6 cases.

• Brand Name: UNKNOWN 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7899074
• MDR Text Key: 121438288
• Report Number: 0009610622-2018-01055
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• 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