MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 RETROGRADE FEMORAL NAIL SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

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

Patient Problems Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental device disposition is unknown, legal matter.

Event Description

As reported: "it is further alleged that during the open reduction with internal fixation of the fracture on (b)(6) 2020, a stryker t2 retrograde femoral nail system was used and allegedly a drill bit broke in the patient's distal femoral metaphysis and was left there unnoticed by everyone in the or.The patient reported 17 months of post operative pain and lack of improvement.She allegedly underwent revision on (b)(6) 2021 where the hardware from the (b)(6) 2020 surgery was removed, including the broken drill bit, and the surgeon did a distal femur replacement and hinge prosthesis, with cemented femoral and tibial stems, tibial augments, and a tibial cone, with a distal femur cerclage cable.".

• Brand Name: UNKNOWN T2 RETROGRADE FEMORAL NAIL SYSTEM
• 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: 13939189
• MDR Text Key: 288112846
• Report Number: 0009610622-2022-00107
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• 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
• Date Manufacturer Received: 03/04/2022
• 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
• Patient Sex: Female