MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL CASE 1; IMPLANT

Catalog Number UNK_KIE

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

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 12/19/2019

Event Type  Death  

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.

Event Description

The manufacturer became aware of a literature published by department of orthopedics, suzhou dushuhu public hospital in china.The title of this report is ¿which implant is better for beginners to learn to treat geriatric intertrochanteric femur fractures: a randomised controlled trial of surgeons, metalwork, and patients¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1016/j.Jot.2019.11.003.This report includes research done on 169 patients between the period january 2011 to february 2017.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 (2) cases of death during hospitalization.The report states during hospitalization, four patients died.Three of them had acute pulmonary embolism or heart failure, and one had multiple organ failure.

Event Description

The manufacturer became aware of a literature published by department of orthopedics, suzhou dushuhu public hospital in china.The title of this report is ¿which implant is better for beginners to learn to treat geriatric intertrochanteric femur fractures: a randomised controlled trial of surgeons, metalwork, and patients¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1016/j.Jot.2019.11.003.This report includes research done on 169 patients between the period january 2011 to february 2017.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 (2) cases of death during hospitalization.The report states during hospitalization, four patients died.Three of them had acute pulmonary embolism or heart failure, and one had multiple organ failure.

Manufacturer Narrative

Please note correction made to section h1.

• Brand Name: UNKNOWN GAMMA3 NAIL CASE 1
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11132097
• MDR Text Key: 225565927
• Report Number: 0009610622-2021-00132
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death