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

Catalog Number UNK_KIE

Device Problems Separation Failure (2547); Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 02/03/2019

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 donauspital wien, in austria.The title of this report is ¿surgical revision for complications after gamma 3-nailing osteosynthesis of proximal humeral fractures¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1007/s00113-019-0607-y.Within that publication which involved 1500 patients, post-operative complications were reported, which allegedly occurred from 2008 to 2013.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 lateral migration of femoral neck screw followed by revision.

Manufacturer Narrative

Please note correction to the device code h6.

Event Description

The manufacturer became aware of a literature published by donauspital wien, in austria.The title of this report is ¿surgical revision for complications after gamma 3-nailing osteosynthesis of proximal humeral fractures¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1007/s00113-019-0607-y.Within that publication which involved 1500 patients, post-operative complications were reported, which allegedly occurred from 2008 to 2013.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 lateral migration of femoral neck screw followed by revision.

• Brand Name: UNKNOWN GAMMA3 NAIL
• 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: 11152398
• MDR Text Key: 226595653
• Report Number: 0009610622-2021-00217
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention