MAUDE Adverse Event Report: KLS MARTIN SE & CO. KG LEVEL ONE; BLADE

Model Number	99-595-22-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Foreign Body In Patient (2687)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during initial surgery that a screwdriver blade broke during use.A portion of it remains implanted in the screw head.Removal is expected during planned treatment.
Additional Manufacturer Narrative
Corrections: d4 - lot kja.D9 - yes; returned to manufacturer 17-dec-2024.

• Brand Name: LEVEL ONE
• Common Device Name: BLADE
• Manufacturer (Section D): KLS MARTIN SE & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KLS MARTIN SE & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: melissa bachorski ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 21029622
• Report Number: 9610905-2024-00079
• Device Sequence Number: 21115355
• Product Code: HXX
• UDI-Device Identifier: 00888118120762
• UDI-Public: (01)00888118120762
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: CLS 1 EXEMPT
• Exemption Number: 2017029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 99-595-22-01
• Device Lot Number: KJA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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: Other
• Patient Age: 15 YR
• Patient Sex: Male