MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 TROCHANTERIC NAIL (11X180MM); IMPLANT

Catalog Number UNK_KIE

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

Patient Problem Bacterial Infection (1735)

Event Date 11/23/2012

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 literature published by department of trauma, hand, and reconstructive surgery, university of giessen and marburg gmbh in germany.The title of this report is ¿use of the gamma3¿ nail in a teaching hospital for trochanteric fractures: mechanical complications, functional outcomes, and quality of life¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1186/1756-0500-5-651.This report includes research done on 90 patients between the period 1 april 2009 and 30 september 2010.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses deep infection caused by staphylococcus aureus which required surgical interventions.The report states: the deep infection occurred in a patient with a a1 trochanteric fracture.In the 1 case of deep wound infection, several surgical revisions were necessary.Unfortunately, the patient died of heart failure during 1 of the revisions.

• Brand Name: UNKNOWN GAMMA3 TROCHANTERIC NAIL (11X180MM)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11453412
• MDR Text Key: 240443754
• Report Number: 0009610622-2021-00348
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/10/2021
• 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