MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL PF, LEFT T2 ALPHA FEMUR ANTEGRADE Ø9X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2335-0936S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a subtrochanteric proximal femur fracture was treated with a t2 alpha pf nail.5 weeks post op the patient reports that as she was walking around her home, she felt and heard a pop and her left leg gave out and she was unable to ambulate and had severe pain.She had a revision surgery to remove the broken nail and it was replaced with a depuy synthes 95 degree blade plate with cortical and locking screws.
Event or Problem Description
It was reported that a subtrochanteric proximal femur fracture was treated with a t2 alpha pf nail.5 weeks post op the patient reports that as she was walking around her home, she felt and heard a pop and her left leg gave out and she was unable to ambulate and had severe pain.She had a revision surgery to remove the broken nail and it was replaced with a depuy synthes 95 degree blade plate with cortical and locking screws.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned and matches the alleged failure.Device inspection revealed the following: the visual inspection confirms the nail breakage, on top and on the bottom of the bore where the fracture occurred are strong impression marks visible, caused by high loads between the nail and the lag screw.The fracture face was inspected under the microscope and the typical characteristics of a fatigue fracture as rest lines are clearly visible.With the available radiographs, a formal medical opinion was sought: a long nail is a good solution for this type of fracture but the reduction was not perfect for this fracture.The early breakage of the nail, may be caused by a lack of stability in the construct and an imperfect reduction.This caused movement in the fracture and nail.These very unstable fractures need an almost perfect reduction.The movement could have led to fatigue and breakage.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause was attributed to patient-related factors.If any additional information is provided, the investigation will be reassessed.

• Brand Name: FEMORAL NAIL PF, LEFT T2 ALPHA FEMUR ANTEGRADE Ø9X360MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16147214
• Report Number: 0009610622-2023-00010
• Device Sequence Number: 6802261
• Product Code: HSB
• UDI-Device Identifier: 07613327285635
• UDI-Public: 07613327285635
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 2335-0936S
• Device Catalogue Number: 23350936S
• Device Lot Number: K01FD34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2019
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 61 KG