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

Catalog Number UNK_KIE

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the orthopedic department of orthopaedic surgery, (b)(6) medical center, affiliated with the (b)(6) medicine and tel aviv university, israel.The article can be found at https://doi.Org/10.1007/s00402-020-03726-7.  the reported event could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.  more detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.   if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device disposition unknown.

Event Description

The manufacturer became aware of a literature published by the orthopedic department of orthopaedic surgery, rabin medical center, affiliated with the sackler faculty of medicine and tel aviv university, israel.The title of this report is expandable proximal femoral nail versus gamma proximal femoral nail for the treatment of hip reverse oblique fractures, published on (b)(6) 2021, and can be found at https://doi.Org/10.1007/s00402-020-03726-7.The report is associated with the stryker gamma 3 nailing system and includes an analysis of the clinical data that was collected on 67 patients.The cases in this study range from july 2008 to february 2016.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that 1 patient experienced non-union.

• Brand Name: UNKNOWN GAMMA 3 PROXIMAL FEMORAL 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: 15342133
• MDR Text Key: 299147024
• Report Number: 0009610622-2022-00410
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 09/01/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/01/2022
• 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): Other