NA 02.214.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982055293), received between Aug 13, 2018 and Oct 26, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF THE SECOND METACARPAL. THE TWO LOCKING SCREWS SELF-TAPPING WOULD NOT LOCK IN TO THE LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE. THE DOCTOR REPLACED THE SCREWS WITH NEW ONES. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 4 MINUTES. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE: LCP CONDYLAR PLATE (PART: 02.114.014, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 1.5MM LOCKING SCREW 12MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8010831 ↗
• MalfunctionAug 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS FOR A VETERINARY CASE. THERE WAS NO HUMAN PATIENT INVOLVEMENT. DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR DISTAL RADIUS FRACTURES ON (B)(6) 2018. DURING THE PROCEDURE, SURGEON ATTACHED TWO (2) BENDING PINS TO A PLATE, THEN TRIED TO CONTOUR THE PLATE USING THE BENDING PINS. HOWEVER, THE BENDING PINS CAME OFF THE PLATE WHILE BENDING. SURGEON ATTEMPTED TO USE TWO (2) OTHER PLATES BUT OBTAINED THE SAME RESULTS. IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE, A LOCKING SCREW WOULD NOT LOCK TO THE PLATES. SURGEON WAS NOT SURE IF THE ISSUE WAS DUE TO THE BENDING PINS OR THE SCREW HOLE ON THE PLATES. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 30 MINUTES AND NO REPORTED CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) 1.5MM LOCKING SCREW. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7779451 ↗
• MalfunctionAug 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS FOR A VETERINARY CASE. THERE WAS NO HUMAN PATIENT INVOLVEMENT. DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT AN OSTEOSYTHESIS FOR DISTAL RADIUS FRACTURES ON (B)(6) 2018. DURING THE PROCEDURE, SURGEON ATTACHED TWO (2) BENDING PINS TO A PLATE, THEN TRIED TO CONTOUR THE PLATE USING THE BENDING PINS. HOWEVER, THE BENDING PINS CAME OFF THE PLATE WHILE BENDING. SURGEON ATTEMPTED TO USE TWO (2) OTHER PLATES BUT OBTAINED THE SAME RESULTS. IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE, A LOCKING SCREW WOULD NOT LOCK TO THE PLATES. SURGEON WAS NOT SURE IF THE ISSUE WAS DUE TO THE BENDING PINS OR THE SCREW HOLE ON THE PLATES. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 30 MINUTES AND NO REPORTED CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) 1.5MM LOCKING SCREW. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7779346 ↗