MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LONG GAMMA 3 NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

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

Patient Problem Malunion of Bone (4529)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition unknown.

Event Description

The manufacturer became aware of a literature published by the department of orthopaedic surgery, liv hospital, istanbul, turkey.The title of this report is ¿reverse oblique and transverse intertrochanteric femoral fractures treated with the long cephalomedullary nail ¿, published on march 26, 2015, which is associated with the stryker ¿gamma 3 nailing¿ system.The article can be found at https://doi.Org/10.1097/bot.0000000000000340.This report includes analysis of the clinical data that was collected on 149 patients, the cases in this study range from january 2000 and march 2013.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that 1 patient experienced malreductions and shortenings, requiring revision.

• Brand Name: UNKNOWN LONG GAMMA 3 NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14047385
• MDR Text Key: 288875734
• Report Number: 0009610622-2022-00123
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• 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