MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, LEFT D11X400MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85251400S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported by rep: "new per for a broken gamma 4 nail.Patient age: 79 gender: female medical concerns: atypical fracture, high risk for implant failure.Date of implantation: (b)(6) 2025.Implant details: 11x400mm (125) left gamma4 nail.Implant id: 8525-1400.Lot number: k1a4934 3 months post-op from implantation: patient came in for review, x-rays shows signs of non-union and patient told they are high risk of implant failure.Date of implant breakage: exact date unknown but breakage identifies on (b)(6) 2025 immediate events prior to implant breakage: (b)(6) 2025 fall (b)(6) 2025: increased hip pain (b)(6) 2025: presented to a+e where leg gave way + x-rays taken to identify broken implant date of revision: (b)(6) 2025 - implant removed and enhanced for proximal femoral plate.Was the patient adversely affected?: yes, patient required a revision procedure consisting of removal of gamma4 nail and insertion of proximal femoral plate on (b)(6) 2025.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned nail is found broken.The device inspection revealed the following: the nail was received and found broken from its proximal web.The load bearing points are clearly visible, indicating high compressive load on the nail post-operative.Broken surface of the nail indicates that crack originated from lateral anterior region of the web and continued to grow due to prolonged cyclic loading as indicated by the lines of rest and finally a sudden catastrophic failure from medial region occurred as indicated by the uneven surface.These observations indicate that fatigue failure has occurred in the nail most probably due to non-union as indicated in the event description as well.It is difficult to say whether the patient fall that has been indicated in the event description caused the crack initiation or it led to the final catastrophic failure.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.Remarks from hcp on the provided x-rays: "the exact root cause cannot be defined as non-unions are, in general, multifactorial.The location and pattern of the fracture, biology, and the technical aspects of the surgical procedure have contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution and, therefore, the breakage of the implants.If more information is provided, the case will be reassessed." based on investigation and hcp feedback, it can be certainly said that the nail broke in a fatigue manner due to repeated cyclic loading but the exact root cause cannot be defined as non-unions are, in general, multifactorial.The location and pattern of the fracture, biology, and the technical aspects of the surgical procedure have contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution and, therefore, the breakage of the implants.If more information is provided, the case will be reassessed.
Event or Problem Description
Reported by rep: "new per for a broken gamma 4 nail.Patient age: 79 gender: female medical concerns: atypical fracture, high risk for implant failure date of implantation: (b)(6) 2025.Implant details: 11x400mm (125) left gamma4 nail.Implant id: 8525-1400.Lot number: k1a4934 3 months post-op from implantation: patient came in for review; x-rays shows signs of non-union and patient told they are high risk of implant failure.Date of implant breakage: exact date unknown but breakage identifies on (b)(6) 2025.Immediate events prior to implant breakage: (b)(6) 2025 fall, on (b)(6) 2025: increased hip pain, (b)(6) 2025: presented to a+e where leg gave way + x-rays taken to identify broken implant.Date of revision: (b)(6) 2025 - implant removed and enhanced for proximal femoral plate.Was the patient adversely affected? yes, patient required a revision procedure consisting of removal of gamma4 nail and insertion of proximal femoral plate on (b)(6) 2025.".
Event or Problem Description
Reported by rep: "new per for a broken gamma 4 nail.Patient age: 79.Gender: female.Medical concerns: atypical fracture, high risk for implant failure.Date of implantation: (b)(6) 2025.Implant details: 11x400mm (125) left gamma4 nail.Implant id: (b)(6).Lot number: k1a4934.3 months post-op from implantation: patient came in for review, x-rays shows signs of non-union and patient told they are high risk of implant failure.Date of implant breakage: exact date unknown but breakage identifies on (b)(6) 2025.Immediate events prior to implant breakage: (b)(6) 2025 fall (b)(6) 2025: increased hip pain (b)(6) 2025: presented to a+e where leg gave way + x-rays taken to identify broken implant.Date of revision: (b)(6) 2025 - implant removed and enhanced for proximal femoral plate.Was the patient adversely affected?: yes, patient required a revision procedure consisting of removal of gamma4 nail and insertion of proximal femoral plate on (b)(6) 2025.".
Additional Manufacturer Narrative
Please note correction to h6 (results and clinical signs code).The reported event could be confirmed, since the returned nail is found broken.The device inspection revealed the following: the nail was received and found broken from its proximal web.The load bearing points are clearly visible, indicating high compressive load on the nail post-operative.Broken surface of the nail indicates that crack originated from lateral anterior region of the web and continued to grow due to prolonged cyclic loading as indicated by the lines of rest and finally a sudden catastrophic failure from medial region occurred as indicated by the uneven surface.These observations indicate that fatigue failure has occurred in the nail most probably due to non-union as indicated in the event description as well.It is difficult to say whether the patient fall that has been indicated in the event description caused the crack initiation or it led to the final catastrophic failure.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.Remarks from hcp on the provided x-rays: "the exact root cause cannot be defined as non-unions are, in general, multifactorial.The location and pattern of the fracture, biology, and the technical aspects of the surgical procedure have contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution and, therefore, the breakage of the implants.If more information is provided, the case will be reassessed." based on investigation and hcp feedback, it can be certainly said that the nail broke in a fatigue manner due to repeated cyclic loading but the exact root cause cannot be defined as non-unions are, in general, multifactorial.The location and pattern of the fracture, biology, and the technical aspects of the surgical procedure have contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution and, therefore, the breakage of the implants.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA4 - LONG NAIL, LEFT D11X400MM 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 GMBH; 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: 23632755
• Report Number: 0008031020-2025-02093
• Device Sequence Number: 15798199
• Product Code: HSB
• UDI-Device Identifier: 07613327474824
• UDI-Public: (01)07613327474824(11)240308(17)340228(10)K1A4934
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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: 85251400S
• Device Lot Number: K1A4934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 03/17/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/25/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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: 79 YR
• Patient Sex: Unknown