MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø11X400MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2337-1140S

Device Problem Difficult to Insert (1316)

Patient Problem Pulmonary Embolism (1498)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "patient was (b)(6) years old male, bmi 24.2, no significant medical history and non-smoker.The injury was due to motor vehicle accident, right femur shaft fracture classified as 32-a3, closed type.During surgery, the right femur was reammed 2 mm over and the nail was impossible to be applied.There was a fracture in the distal femur after multiple tries.The femur 11x*400 t2 alpha femoral nail pf was removed and a regular t2 nail was applied with the same dimensions with no complications.Patient had pulmonary embolism the day of surgery and was discharged 4 days after surgery with no complications.He is 149 days after surgery with a fracture that is healed about 5 months postoperatively." additionally reported by rep: "due to the type of fracture patient sustained the 11x*400 t2 alpha femoral nail pf could not be inserted therefore the surgeon decided to remove it and install regular t2.The t2 alpha nail did not create or contributed to any additional intra operative fractures." rep also indicated that the surgeon used reamers from zimmer.

• Brand Name: FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø11X400MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9998524
• MDR Text Key: 192180419
• Report Number: 0009610622-2020-00173
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327289015
• UDI-Public: 07613327289015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2337-1140S
• Device Catalogue Number: 23371140S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• 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): Other
• Patient Age: 16 YR