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

Model Number	1825-1240S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Swelling/ Edema (4577)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.Device remains implanted.
Event or Problem 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.".
Event or Problem Description
The customer "gd" reported to ansm 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 on (b)(6) 2021, that's what made me decide to fill in these fields.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR Ø12X400 MM
• Common Device Name: 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
• Report Number: 0009610622-2021-00732
• Device Sequence Number: 14266751
• Product Code: HSB
• UDI-Device Identifier: 04546540199799
• UDI-Public: 04546540199799
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K010801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2022
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown