MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - LONG NAIL KIT R1.5, TI, LEFT D11X420MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251420S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that after 6 month, the nail was removed since it broke off at the cephalic screw part.
Event or Problem Description
It was reported that after 6 month, the nail was removed since it broke off at the cephalic screw part.
Additional Manufacturer Narrative
The reported event could be confirmed since evaluation matches the reported failure mode.In the case presented an unknown patient was initially treated on (b)(6) 2024 with above shown gamma3 - long nail, which was noticed to be broken as per event details given ¿6 months after the surgery in which the nail was inserted¿ the received nail is completely broken in the webs of the proximal lag screw thru hole.According to the damage and the evidence of the breakage surfaces, the nail broke in a fatigue fracture.Appearance identified a high axial load application to the implants which is also supported by signs of damage verified at one locking screw.Areas with signs of friction / seizing (bearing points of lag screw) are visible at the distal medial edge.The counterparts were found on the lag screw in the areas with corresponding friction signs and worn edges.Bearing points are typical results of the interaction of the single products under load.Based on investigation the nail breakage is not linked to a deficiency of the device but is rather considered patient and / or procedure related.However, an exact root cause could not be determined.It could not be excluded that the implant had to absorb / transfer the whole loading because it was not relieved by increasing bone healing.Due to missing x-rays, it could not be determined whether reduction had been performed according to anatomical requirements and furthermore, if the implant positioning was according to anatomical requirements as well.Furthermore, as no further information such as x-rays, medical records or surgery reports was provided, a real medical statement was impossible.Finally, 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.General aspects: the gamma3 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.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.According to available information a deficiency of the nail was not verified.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: GAMMA3 - LONG NAIL KIT R1.5, TI, LEFT D11X420MM X 125DEG
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22632285
• Report Number: 0008031020-2025-01306
• Device Sequence Number: 20831667
• Product Code: HSB
• UDI-Device Identifier: 07613252274308
• UDI-Public: (01)07613252274308(17)271130(10)K0A9635
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 35251420S
• Device Lot Number: K0A9635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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: Unknown