MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - INTERMEDIATE NAIL, LEFT D10X240MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	83250240S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the patient underwent a revision surgery due to the nail breaking at the lag screw junction".
Event or Problem Description
As reported: "the patient underwent a revision surgery due to the nail breaking at the lag screw junction".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged issue.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.There are mis-drilling marks observed along the inner surface of the posterior web, majorly towards medial and some of it around the lateral side as well - most likely created by a deviated lag screw step drill, potentially creating a starting point for crack propagation.The fracture appears to have started from the lateral edge on the posterior web and progressed towards medial.The fracture pattern resembles a fatigue fracture, evident by visible lines of rest progressing from lateral to medial, relatively smooth fracture surface on initiation side (posterior web) and abrupt feature on the other side.The breakage initiated in a fatigue manner and broke instantaneously from the other side due to high tension and loading.There are signs of high axial loading evident by presence of heavy lag screw bearing marks on the lateral edge of the proximal segment, superiorly and on the medial edge of the distal portion.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.No indications of material, manufacturing or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the provided information, the nail broke from the proximal hole due to fatigue failure.The likely reason for it could be attributed to overloading & patient related factors but an exact root cause cannot be determined until more information like patient information and medical records are available for further evaluation.If any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA4 - INTERMEDIATE NAIL, LEFT D10X240MM 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 GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24640810
• Report Number: 0008031020-2026-00427
• Device Sequence Number: 18602552
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: 83250240S
• Device Lot Number: K132095
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 195 LB
• Patient Race: White