MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE LOCKING SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 04/01/2018

Event Type  malfunction  

Event Description

The manufacturer became aware of a literature published by the department of orthopedic surgery, the affiliated drum tower hospital of nanjing university medical school, china.The title of this report is ¿reconstruction of bone defect with allograft and retrograde intramedullary nail for distal tibia osteosarcoma¿, published on april 01, 2018, which is associated with the stryker ¿t2 ankle locking screw¿.The article can be found at http://dx.Doi.Org/10.1016/j.Fas.2017.01.006.This report includes analysis of the clinical data that was collected on 5 patients, and the cases in this study range from march 2010 to may 2014.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 screw breakage.The report states, ¿besides, screw breakage was found at 4 years after surgery in patient no.1.Considering that excellent fusion had been achieved, we performed no treatment to the fractured screw, and no complaint was reported by the patient in the follow-up.¿.

Manufacturer Narrative

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

• Brand Name: UNKNOWN T2 ANKLE LOCKING SCREW
• 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: 14112185
• MDR Text Key: 289272434
• Report Number: 0009610622-2022-00136
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/17/2022
• Initial Date FDA Received: 04/14/2022
• 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