MAUDE Adverse Event Report: SKY SURGICAL GSOURCE; SCREWDRIVER BIT, T6 TAPERED

Model Number	86.1606
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgical instrument tip left in implant in situ.

• Brand Name: GSOURCE
• Common Device Name: SCREWDRIVER BIT, T6 TAPERED
• Manufacturer (Section D): SKY SURGICAL; 8600 nw 64th street, #203; parkville MN 64152
• Manufacturer (Section G): GSOURCE; 19 bland street; emerson NJ 07630
• Manufacturer Contact: jeff sander ; 8600 nw 64th street, #203; parkville, MO 64152 ; 8168146904
• MDR Report Key: 22351968
• Report Number: 3030691054-2025-00003
• Device Sequence Number: 8574071
• Product Code: HXX
• UDI-Device Identifier: 00840314245656
• UDI-Public: 00840314245656
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 86.1606
• Device Catalogue Number: 86.1606
• Device Lot Number: 2110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female