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

Model Number	001-1-07
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgical instrument tip left in implant in situ.
Event or Problem Description
Surgical instrument tip left in implant in situ.

• Brand Name: SKYOPS
• Common Device Name: SCREWDRIVER BIT, T6 TAPERED
• Manufacturer (Section D): SKY SURGICAL; 8600 nw 64th street, #203; parkville MN 64152
• Manufacturer (Section G): PRECISION ADM; unit 3 - 725 black diamond blv; winnipeg, manitoba R3T 1 M1; CA R3T 1M1
• Manufacturer Contact: jeff sander ; 8600 nw 64th street, #203; parkville, MO 64152 ; 8168146904
• MDR Report Key: 21999180
• Report Number: 3030691054-2025-00002
• Device Sequence Number: 12579440
• Product Code: HXX
• UDI-Device Identifier: 00850024702448
• UDI-Public: 00850024702448
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 05/09/2025

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: 001-1-07
• Device Catalogue Number: 001-1-07
• Device Lot Number: C9940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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: 35 YR
• Patient Sex: Male