MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø12X400 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1825-1240S

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

Patient Problems Fatigue (1849); Headache (1880); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Swelling/ Edema (4577)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report. Device remains implanted.

Event Description

The customer (b)(6) reported to (b)(6) that: "right leg swollen, hard to the touch. Remains swollen for several hours after observation, until lying down, even though the leg was left in the open air without restraint (no socks or tight clothes). Shortness of breath and feeling of tiredness, headaches (occipital lobe area and frontal lobe area), very slight prickling sensation in the heart. The swollen legs, i observed them from (b)(6) 2006 to (b)(6) 2021, that's what made me decide to fill in these fields. ".

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR Ø12X400 MM
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12583904
• MDR Text Key: 274974071
• Report Number: 0009610622-2021-00732
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K010801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1825-1240S
• Device Catalogue Number: 18251240S
• Device Lot Number: K038533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• 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: 10/06/2021 Patient Sequence Number: 1