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
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem 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
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9998524
• Report Number: 0009610622-2020-00173
• Device Sequence Number: 11687330
• Product Code: HSB
• UDI-Device Identifier: 07613327289015
• UDI-Public: 07613327289015
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2020

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: Health Professional
• Device Model Number: 2337-1140S
• Device Catalogue Number: 23371140S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR