MAUDE Adverse Event Report: GSOURCE; STEIN, PIN S. TROC RD 12" 2.4MM

Model Number	GS 78.5824
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned for review.Review of the device history record did not indicate an abnormalities that would contribute to the incident.A definitive root cause could not be drawn with the information available for this investigation.
Event or Problem Description
While placing screws for an si-joint fusion, steinmann pin broke, llaving and 8mm retained pin fragment.The pin tip could not be removed (fragment).It was near the nerve root.The patient had resulted ls neuropraxia and weak extensors of her foot as a result.Due to the location of the retained pin , it would be inadvisable to remove the pin.

• Common Device Name: STEIN, PIN S. TROC RD 12" 2.4MM
• Manufacturer (Section D): GSOURCE; 19 bland street; emerson NJ 07630
• Manufacturer Contact: tracy huling ; 400 erin drive; knoxville, TN 37919 ; 8652433967
• MDR Report Key: 25093936
• Report Number: 3005819474-2026-00003
• Device Sequence Number: 10018022
• Product Code: LXH
• UDI-Device Identifier: 00840314240934
• UDI-Public: 00840314240934
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: Health Professional
• Device Model Number: GS 78.5824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female