MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA SYSTEM; HEADED SCREW DIA. 3 MM X L. 50 MM

Model Number	9095.11.D50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Checking the manufacturing charts of the components involved in the event, no pre-existing anomaly was found in the items belonging to the same product code and lot number.This is the first complaint received on the lot number 2523343.The manufacturer will submit a final report as soon as the investigation is complete.
Event or Problem Description
During a knee surgery (lateral uni), two headed screw l.50 mm (product code: 909511d50s, lot: 2523343 - ster.(b)(4) pins broke.Both broken parts are retained in the patient's femur.The event occurred as the surgeon unscrewed the femoral cut block.The procedure was delayed of 10 minutes.Event occurred in united kingdom.

• Brand Name: PHYSICA SYSTEM
• Common Device Name: HEADED SCREW DIA. 3 MM X L. 50 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; san daniele del friuli; villanova
• MDR Report Key: 23345066
• Report Number: 3008021110-2025-00140
• Device Sequence Number: 13129186
• Product Code: LXH
• UDI-Device Identifier: 08033390123693
• UDI-Public: 08033390123693
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9095.11.D50
• Device Catalogue Number: 9095.11.D50
• Device Lot Number: 2523343
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown