MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, LEFT D12X360MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85252360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/06/2025
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
As reported: "yesterday a broken longer gamma4 nail was removed - it broke within the last 6 weeks after implantation.The patient came out of rehab and suddenly experienced severe pain while walking.".
Additional Manufacturer Narrative
Correction: please refer to section h6 (health impact 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 it was found broken from its proximal web.Proximal web and surface around it is severely damaged, most probably due to interaction between broken fragments and other implants.Load bearing points are significantly uneven, indicating uneven load distribution.Microscopic images of the broken fragments indicate that the crack initiation has happened from lateral anterior side, after that very fine lines of rest are visible in the distal fragment on the anterior side.Simultaneously, a secondary crack propagation is seen on the lateral posterior side.Ultimately, the final instantaneous failure (highlighted red) has happened at the medial portion of the nail which is predominantly observed in the posterior web as indicated by slightly distorted surface with a shear lip.These observations indicate a fatigue failure of the material.However, the crack initiation due to misdrilling could not be confirmed since this region of the nail is significantly damaged.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 investigation, it can be certainly said that the nail broke in a fatigue manner due to repeated cyclic loading.However, an exact root cause of the event could not established since some vital information like post-operative x-rays are not available at this time.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "yesterday a broken longer gamma4 nail was removed - it broke within the last 6 weeks after implantation the patient came out of rehab and suddenly experienced severe pain while walking." 7/14/2025 - additional information received: any remarkable circumstances related to the event? (e.G., additional trauma, disease, delayed or non-union) post-rehabilitation, no trauma how was the event resolved? implant removal of nail, re-osteosynthesis with new nail + angular stable plate + cancellous bone graft.

• Brand Name: GAMMA4 - LONG NAIL, LEFT D12X360MM 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: 22570535
• Report Number: 0008031020-2025-01294
• Device Sequence Number: 4022011
• Product Code: HSB
• UDI-Device Identifier: 07613327475166
• UDI-Public: (01)07613327475166(11)240219(17)340131(10)K199FF6
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 85252360S
• Device Lot Number: K199FF6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 78 KG