MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL RETROGRADE T2 ALPHA FEMUR RETROGRADE Ø11X420MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391142S
Medical Device Problem Codes	Crack (1135); Noise, Audible (3273)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/17/2024
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.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
As reported: "the patient was walking around her home and heard a crack.The nail broke at the most proximal distal screw hole of the nail.".
Event or Problem Description
As reported: "the patient was walking around her home and heard a crack.The nail broke at the most proximal distal screw hole of the nail.".
Additional Manufacturer Narrative
Please note the correction to d4 gtin.The reported event could be confirmed based on details provided, only.Images available revealed a broken nail at the most proximal distal screw hole of the nail.Due to missing device a physical evaluation was impossible and further technical statement could not be given.In the case presented a female patient was primarily treated with a femoral nail retrograde t2 alpha femur retrograde dimensions 11x420mm on july 21, 2024, and was revised on october 18, 2024 by a right alpha gt recon nail and right 10 hole axsos3 distal lateral femoral plate.As no item was returned no physical examination could be carried out.Due to missing product, it could not be determined in what manner nail had broken.As the nail was not available it could not be determined if the nail had been damaged intra-operatively.General aspects: the nail is a temporary implant which inevitably will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation.During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product.Usually, a breakage is contributed by one or more deficits, e.G.Insufficient bone healing, product damage.Generally, the risk of a breakage will increase with the increase of load cycles and load level.Nail breakage in general has been experienced but does not present an unanticipated event in itself.Depending on load application, also, depending on the patient¿s post implant behaviour and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e.G.Increased post-operative activities ¿ a nail breakage can rather be classified as anticipated; specifically if one or more contributing issues concurrence with each other.It could not be determined what range of weight bearing had been advised by the surgeon for the post-operative period.It could also not be determined if the patient had been compliant to the instructions.In the corresponding ifu and operative technique applicable warnings related to this failure mode are noted.Based on received information and referring to that no deviation was found in the manufacturing documents a deficiency in the nail in question was not verified.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.In case the item and / or substantive information will become available in future we reserve the right to update the investigation and to change the root cause.

• Brand Name: FEMORAL NAIL RETROGRADE T2 ALPHA FEMUR RETROGRADE Ø11X420MM
• 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: 20679627
• Report Number: 0009610622-2024-00912
• Device Sequence Number: 20978381
• Product Code: HSB
• UDI-Device Identifier: 07613327293685
• UDI-Public: (01)07613327293685(17)330228(10)K11D897
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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 Catalogue Number: 23391142S
• Device Lot Number: K11D897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2023
• 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 Sex: Female