MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN 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 Necrosis (1971)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of ipsilateral osteonecrosis 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 medical history, the event circumstances, radiographs and the involved device(s) must be available in order 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 ¿department of orthopaedic surgery, st.Vincent¿s hospital, the catholic university of korea, republic of korea¿.The title of this report is ¿additional use of anti-rotation u-blade (rc) decreases lag screw sliding and limb length inequality in the treatment of intertrochanteric fractures¿, published on august 31, 2021, which is associated with the stryker ¿gamma 3 nailing system¿.The article can be found at https://doi.Org/10.1038/s41598-021-96988-z.This report includes an analysis of the clinical data that was collected on 152 patients.The cases in this study range from january 2014 to december 2018.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced ipsilateral osteonecrosis.The report states, ¿¿there was one patient with ipsilateral osteonecrosis and two with distal locking screw breakage postoperatively, neither of whom required any further management".

• Brand Name: UNKNOWN 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: 14824528
• MDR Text Key: 294942740
• Report Number: 0009610622-2022-00301
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/26/2022

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: 06/01/2022
• Initial Date FDA Received: 06/26/2022
• 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