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

Catalog Number UNK_KIE

Device Problem Separation Problem (4043)

Patient Problem Injury (2348)

Event Date 08/20/2014

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 università degli studi di modena e reggio emilia in italy.The title of this report is ¿causes and treatments of lag screw¿s cut out after intramedullary nailing osteosynthesis for trochanteric fractures¿ which is associated with the stryker ¿gamma3¿ nailing system.The article can be found at https://www.Mattioli1885journals.Com/index.Php/actabiomedica/article/view/2912.Within that publication which included 20 patients, post-operative complications were reported, which allegedly occurred from september 2004 to november 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 cut out of lag screw which was treated by total hip arthroplasty.The report states: ¿the treatment performed was: in 1 patient the removal of the implant, in 3 cases the reosteosynthesis (in 2 cases only of the lag screw) and in 16 patients hip arthroplasty: 13 total and 3 partial hip arthroplasty [.] causes of cutting out (mechanical, biological, mixed) mixed (nonunion and malriduction) [.] time of cutting out (months) 6 [.] treatment total hip arthroplasty: cementless straight modular stem + acetabular cup¿.

• 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; DE D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10335353
• MDR Text Key: 202881421
• Report Number: 0009610622-2020-00408
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 07/01/2020
• 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
• Patient Age: 44 YR