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

Catalog Number UNK_KIE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This product inquiry addresses deep infection.The pmcfr states: ¿a patient was found to have deep infection of the implanted hardware; underwent irrigation and debridement of the surgical wound and had positive cultures for bacillus species, an anaerobic bacteria species.This infection resolved following surgical irrigation and debridement and intravenous antibiotics.¿ the manufacturer became aware of a post market clinical follow-up report (pmcfr) from (b)(6).The title of this report is a post-market clinical follow-up (pmcf) of the treatment of femoral fractures with the t2 greater trochanter entry femoral nailing system (gtn) which was published in june 2018 and is associated with the t2 greater trochanter entry femoral nailing system (gtn).Within that publication 3 adverse events were reported, which occurred between 2012 to 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 had not been reported by the hospital or by the author of the publication, therefore 3 complaints were initiated retrospectively.All 3 adverse events involved static mode 1.All 3 adverse events took place on the right side.

• Brand Name: UNK GTN 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: 7656244
• MDR Text Key: 112993566
• Report Number: 0009610622-2018-00257
• Device Sequence Number: 1
• Product Code: HSB
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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: 06/11/2018
• 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