PHYSICA system 9095.11.D50Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390123693), received between Mar 24, 2021 and Oct 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Break; Break

  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.

  Patient problems: Insufficient Information

  MAUDE report 23345066 ↗
• MalfunctionMar 24, 2021Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem

  DURING KNEE SURGERY PERFORMED ON (B)(6) 2021, IT WAS NOT POSSIBLE TO UNSCREW THE PIN EXAGONAL HEAD SCREW DIA.3X50 MM (PRODUCT CODE 9095.11.D50, LOT #19AT42Z). THE ISSUE OCCURRED DURING USE WITH THE POWERED PIN DRIVER EXAGONAL HEAD (PRODUCT CODE 9095.11.121, LOT 19AG08L). ACCORDING TO COMPLAINT SOURCE, PATIENT'S BONE WAS HARD. THE PIN WAS THEN REMOVED USING FORCEPS AND THE SURGERY WAS EXTENDED BY 20 MINUTES. THIS EVENT OCCURRED IN ITALY. NOTE: THIS COMPLAINT WAS REPORTED TO FDA AS THE PIN IS FDA CLEARED. HOWEVER, IN THIS CASE IT WAS USED IN COMBINATION WITH A POWERED PINDRIVER DURING A PHYSICA ZUK KNEE SURGERY, WHICH IS NOT COMMERCIALIZED IN THE USA.

  Patient problems: Insufficient Information

  MAUDE report 11560631 ↗
• MalfunctionMar 24, 2021Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem

  DURING KNEE SURGERY PERFORMED ON (B)(6) 2021, IT WAS NOT POSSIBLE TO UNSCREW THE PIN EXAGONAL HEAD SCREW DIA.3X50 MM (PRODUCT CODE 9095.11.D50, LOT #19AT07Y). THE ISSUE OCCURRED DURING USE WITH THE POWERED PIN DRIVER EXAGONAL HEAD (PRODUCT CODE 9095.11.121, LOT 19AG08L). ACCORDING TO COMPLAINT SOURCE, PATIENT'S BONE WAS HARD. THE PIN WAS THEN REMOVED USING FORCEPS AND THE SURGERY WAS EXTENDED BY 20 MINUTES. EVENT OCCURRED ON ITALY. NOTE: THIS COMPLAINT WAS REPORTED TO FDA AS THE PIN IS FDA CLEARED. HOWEVER, IN THIS CASE IT WAS USED IN COMBINATION WITH A POWERED PINDRIVER DURING A PHYSICA ZUK KNEE SURGERY, WHICH IS NOT COMMERCIALIZED IN THE USA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11560628 ↗
• MalfunctionMar 24, 2021Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem

  DURING KNEE SURGERY PERFORMED ON (B)(6) 2021, IT WAS NOT POSSIBLE TO UNSCREW THE PIN EXAGONAL HEAD SCREW DIA.3X50 MM (PRODUCT CODE 9095.11.D50, LOT 19AT07Y) . THE ISSUE OCCURRED DURING USE WITH THE POWERED PIN DRIVER EXAGONAL HEAD (PRODUCT CODE 9095.11.121, LOT 19AG08L). ACCORDING TO COMPLAINT SOURCE, PATIENT'S BONE WAS HARD. THE PIN WAS THEN REMOVED USING FORCEPS AND THE SURGERY WAS EXTENDED BY 20 MINUTES. EVENT OCCURRED IN ITALY. NOTE: THIS COMPLAINT WAS REPORTED TO FDA AS THE PIN IS FDA CLEARED. HOWEVER, IN THIS CASE IT WAS USED IN COMBINATION WITH A POWERED PINDRIVER DURING A PHYSICA ZUK KNEE SURGERY, WHICH IS NOT COMMERCIALIZED IN THE USA.

  Patient problems: Insufficient Information

  MAUDE report 11560626 ↗