MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23371036S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "post-market clinical evaluation of the treatment of femur fractures with the femoral nail greater trochanter (gt)of the t2 alpha femur antegrade gt/pf nailing system.Subject: 03-072.(b)(6) 2024: bone not consolidated at 6-month post-op clinic visit.Patient is on bisphosphonates and chemotherapy so surgeon expects healing to be slower than normal.Significant callus has developed and bone in the process of healing.Patient to return for repeat x-ray in 2 months.If union not achieved at that point will discuss surgical treatment options.".

• Brand Name: FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X360MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 20010232
• Report Number: 0009610622-2024-00797
• Device Sequence Number: 11848071
• Product Code: HSB
• UDI-Device Identifier: 07613327289145
• UDI-Public: 07613327289145
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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 Catalogue Number: 23371036S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 59 KG