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

Catalog Number UNK_KIE

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

Patient Problems Fall (1848); Limb Fracture (4518)

Event Date 11/06/2019

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.

Event Description

The manufacturer became aware of a literature published by hospital of southern denmark, in denmark.The title of this report is ¿failure of short versus long cephalomedullary nail after intertrochanteric fractures¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1016/j.Jor.2019.10.018.Within that publication which included 216 patients, post-operative complications were reported, which allegedly occurred from 1st january 2012 to 31st december 2012.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 ipsilateral fracture (long nail) for which reoperation was performed.The report states: ¿the ipsilateral fracture in the ln group was caused by a subsequently fall.¿.

Event Description

The manufacturer became aware of a literature published by hospital of southern denmark, in denmark.The title of this report is ¿failure of short versus long cephalomedullary nail after intertrochanteric fractures¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1016/j.Jor.2019.10.018.Within that publication which included 216 patients, post-operative complications were reported, which allegedly occurred from 1st january 2012 to 31st december 2012.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 ipsilateral fracture (long nail) for which reoperation was performed.The report states: ¿the ipsilateral fracture in the ln group was caused by a subsequently fall.¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged ipsilateral fracture mentioned in the article could not be confirmed, however, the literature clearly indicates that ipsilateral fracture in the ln group was caused by a subsequent fall, so it can be concluded that the event is patient-related.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

• Brand Name: UNKNOWN GAMMA3 LONG 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: 11015732
• MDR Text Key: 221726247
• Report Number: 0009610622-2020-00989
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention