MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL 180 MM; IMPLANT

Catalog Number UNK_KIE

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

Patient Problems Bone Fracture(s) (1870); Limb Fracture (4518)

Event Date 10/30/2014

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.

Event Description

The manufacturer became aware of a literature published by department of traumatic orthopedics, tianjin hospital, china.The title of this report is ¿analysis of complications of intertrochanteric fracture treated with gamma 3 intramedullary nail¿ published on october 30, 2014, which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at issn:1940-5901/ijcem0001817.This report includes research done on 186 patients and data collection period not mentioned in the literature.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 a refracture of distal femoral shaft in locking screw point.

Event Description

The manufacturer became aware of a literature published by department of traumatic orthopedics, tianjin hospital, china.The title of this report is ¿analysis of complications of intertrochanteric fracture treated with gamma 3 intramedullary nail¿ published on october 30, 2014, which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at issn:1940-5901/ijcem0001817.This report includes research done on 186 patients and data collection period not mentioned in the literature.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 a refracture of distal femoral shaft in locking screw point.

Manufacturer Narrative

Please note corrections to section b2 and h6 (clinical signs and health impact codes).This complaint has been generated based on findings discovered during post market surveillance literature review.The refracture of distal femoral shaft mentioned in the article could not be confirmed since no other additional information was received from the author or the article.More detailed information about the patient medical history, the event circumstances and medical reports must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

• Brand Name: UNKNOWN GAMMA NAIL 180 MM
• 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: 12610602
• MDR Text Key: 280572131
• Report Number: 0009610622-2021-00745
• 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: 10/20/2021

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: 09/17/2021
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention