SynFrame 387.361Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034771175), received between Aug 13, 2019 and May 4, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (2 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 18, 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.

• MalfunctionMay 4, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE HANDLE OF THE ANGLED RASP WAS BROKEN, AND THE MECHANISM IN THE BLADE HOLDER WAS STUCK. THE THREADS WERE WORN OUT ON THE PROBE, AND THE TIP WAS BENT ON THE X25 INSERTER. THERE WAS NO PATIENT INVOLVEMENT OR SURGICAL DELAY. PROCEDURE WAS COMPLETED WITH A SIMILAR PRODUCT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYNFRAME RETRACTOR HOLDER- ADJUSTABLE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870930 ↗
• MalfunctionNov 10, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 DURING A PROCEDURE, THE LOCKING BUTTON ON SYNFRAME RETRACTOR HOLDER-ADJUSTABLE CAN BE PUSHED FROM SIDE TO SIDE, BUT THE TOOTH WHEELS CANNOT BE MOVED SO THAT THE POSITION OF THE WOUND HOOKS THAT WE FASTEN ON CAN BE CHANGED. THE PROCEDURE WAS COMPLETED WITH SIMILAR PRODUCT. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SYNFRAME RETRACTOR HOLDER- ADJUSTABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15772754 ↗
• MalfunctionDec 27, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SYNFRAME RETRACTOR HOLDER- ADJUSTABLE WAS NOT FUNCTIONING. IT WAS UNKNOWN IF SURGERY DELAYED AND PATIENT WAS INVOLVED OR NOT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9525708 ↗
• MalfunctionAug 13, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF THE CENTRAL STERILE PROCESSING DEPARTMENT ON (B)(6) 2019, A SYNFRAME RETRACTION HOLDER-ADJUSTABLE WAS STUCK AND THE ARM WOULD NOT ARTICULATE. WHEN PUSHING THE BUTTON ON THE INSTRUMENT, IT WILL NOT MOVE, AND IT SHOULD. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SYNFRAME RETRACTOR HOLDER- ADJUSTABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8887520 ↗