MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL 180 MM CASE 4; IMPLANT

Catalog Number UNK_KIE

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

Patient Problem Impaired Healing (2378)

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 5 cases of fracture re-displacement.The report states: ¿fracture re-displacement occurred in 5 cases [¿] the time in bed of patients was prolonged in the cases of refracture of femur shaft during the gamma 3 nail inserting into the medullary cavity, fractures with a gap or malalignment in closed reduction of a3 type, postoperatively fracture re-displace¬ment and cut-out of lag screws.They achieved union for a maximum of 4 months.

• Brand Name: UNKNOWN GAMMA NAIL 180 MM CASE 4
• 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: 12610597
• MDR Text Key: 281334013
• Report Number: 0009610622-2021-00746
• 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
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

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