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

Catalog Number UNK_KIE

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

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported the following issue: "current patient status: post-operative infection requiring reoperation for removal of hardware, with risk of femoral fracture or extraction failure. Actions taken in the care facility to manage the patient: antibiotic therapy for 6 weeks.

Manufacturer Narrative

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

Event Description

The customer reported the following issue: "current patient status: post-operative infection requiring reoperation for removal of hardware, with risk of femoral fracture or extraction failure. Actions taken in the care facility to manage the patient: antibiotic therapy for 6 weeks.

• Brand Name: UNKNOWN FEMORAL T2 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: 13619665
• MDR Text Key: 286252356
• Report Number: 0009610622-2022-00073
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 05/03/2022
• 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 Treatment Data

Date Received: 02/28/2022 Patient Sequence Number: 1