NA 399.097Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982202338), received between Aug 24, 2018 and Nov 12, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT DURING THE INTERVENTION, THE FIXED ROD OF THE RACK BROKE SHARPLY. THE DEVICE WAS CHANGED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537926 ↗
• MalfunctionSep 3, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. BEFORE SURGERY, WHEN THE INSTRUMENT WAS STERILIZED UPON DELIVERY, IT WAS CONFIRMED THAT THE BONE-SPREADER IN QUESTION WAS MALFUNCTIONING. IT COULD BE LOCKED BUT SEEMED DIFFICULT TO OPEN. HOWEVER, SINCE THE BONE-SPREADER IN QUESTION WAS A SPARE INSTRUMENT THAT WOULD NOT BE USED IN SURGERY, IT WAS STERILIZED AS IT IS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952038 ↗
• MalfunctionJul 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED A POSTERIOR DECOMPRESSION SURGERY PERFORMED WAS PERFORMED ON (B)(6) 2024. IN THE SURGERY, RATCHET ENGAGEMENT OF THE BONE-SPREAD IN QUESTION WAS EXTREMELY POOR AND OPERABILITY WAS PROBLEMATIC. SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE BONE SPREADER WITH 8MM BLADE MEDIUM HANDLE-SOFT RATCHET THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19762971 ↗
• MalfunctionJan 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT BONE SPREADER WITH 8MM BLADE WAS UNABLE TO LOCK. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) BONE SPREADER WITH 8MM BLADE MEDIUM HANDLE-SOFT RATCHET THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253183 ↗
• MalfunctionAug 18, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INSPECTION IT WAS FOUND OUT THAT THE RATCHET ON A BONE-SPREAD SOFTLO W/8 L220 WOULD NO LONGER HOLD. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) UNK, SCREWS: DISTAL FEMUR. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339510 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BONE SPREADER LATCH WAS NOTED BROKEN. THE ITEM WAS NOTICED IN STERILE PROCESSING WHEN ASSEMBLING TRAYS. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) BONE SPREADER WITH 8MM BLADE MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077636 ↗
• MalfunctionMar 23, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE TEETH OF THE TOMOFIX LAMINAR SPREADER ARE WORN DOWN. IT WAS NOTICED BY SCRUB NURSE AND A DIFFERENT SPREADER WAS USED INSTEAD. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THIS REPORT IS FOR A TOMOFIX LAMINAR SPREADER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9864850 ↗
• MalfunctionJun 26, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING TOMOFIX PROCEDURE, A BONE SPREADER WAS FOUND TO BE WORN OUT. A NEW BONE SPREADER WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND WAS NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) BONE SPREADER WITH 8MM BLADE MEDIUM HANDLE-SOFT RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736421 ↗
• MalfunctionAug 24, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN OPERATION THE DISTRACTOR WAS NOTED TO BE IN POOR CONDITION. THE DEVICE WAS NOTED TO BE WORN AND NOT WORKING AS EXPECTED. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE OPERATION WITH NO DELAY AND NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7813941 ↗