NA 03.305.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587009933), received between Sep 24, 2020 and Sep 24, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K040169); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2020Device-Device Incompatibility; Difficult to Open or Close; Mechanical Jam; Device-Device Incompatibility; Difficult to Open or Close; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE SURGERY TO PLACE THE EXTERNAL FIXATOR OF THE MANDIBULA, WHILE USING TWO (2) ADJUSTABLE CLAMPS, THE NUTS WERE HARD AND GLUED AND IT WAS NOT POSSIBLE TO LOOSEN THEM EASILY. IT WAS NECESSARY TO WAIT TO STERILIZE THE INSTRUMENTS TO BE ABLE TO RELEASE THEM, WHICH CAUSED AN INCREASE IN SURGICAL TIME. IN ADDITION IT HAD TO BE SUPPLEMENTED WITH AN ADDITIONAL PATELLA OF THE EXTERNAL CUFF FIXATOR. THE PROCEDURE WAS COMPLETED SATISFACTORILY. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) ADJUSTABLE CLAMP FOR MANDIBLE EXTERNAL FIXATOR. . THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10581853 ↗
• MalfunctionSep 24, 2020Device-Device Incompatibility; Difficult to Open or Close; Mechanical Jam; Device-Device Incompatibility; Difficult to Open or Close; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE SURGERY TO PLACE THE EXTERNAL FIXATOR OF THE MANDIBULA, WHILE USING TWO (2) ADJUSTABLE CLAMPS, THE NUTS WERE HARD AND GLUED AND IT WAS NOT POSSIBLE TO LOOSEN THEM EASILY. IT WAS NECESSARY TO WAIT TO STERILIZE THE INSTRUMENTS TO BE ABLE TO RELEASE THEM, WHICH CAUSED AN INCREASE IN SURGICAL TIME. IN ADDITION IT HAD TO BE SUPPLEMENTED WITH AN ADDITIONAL PATELLA OF THE EXTERNAL CUFF FIXATOR. THE PROCEDURE WAS COMPLETED SATISFACTORILY. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) ADJUSTABLE CLAMP FOR MANDIBLE EXTERNAL FIXATOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10581833 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040169. One submission often covers many models, so check the product and lot details in each record.

• Z-1009-2015 · Oct 17, 2014 · Terminated
  The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305