DHS 281.540SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982177599), received between Jan 19, 2018 and Jan 19, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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. 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.

• InjuryJan 19, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A HIP PROCEDURE, ON AN UNKNOWN DATE IN (B)(6), THE SURGEON WAS UNABLE TO ENGAGE THE HIP SCREW USING A 135-DEGREE DYNAMIC HIP SCREW PLATE (2 HOLE WITH A SHORT BARREL). THE SURGEON ATTEMPTED TO ENGAGE THE HIP SCREW (X1) USING TWO SEPARATE SHORT BARREL PLATES WITHOUT SUCCESS AND SUBSEQUENTLY SWITCHED TO A STANDARD BARREL. THERE WAS A SLIGHT DELAY IN THE PROCEDURE DUE TO SWITCHING TO THE STANDARD BARREL PLATE. TO THE REPORTER¿S KNOWLEDGE, THERE WERE NO ADDITIONAL CONSEQUENCES. THE HIP SCREW AND THE STANDARD BARREL PLATE WERE SUCCESSFULLY IMPLANTED WITHOUT ANY FURTHER CONSEQUENCE TO THE PATIENT. THERE WAS AN ESTIMATED DELAY OF FIFTEEN (15) MINUTES WHILE THE SURGEON SWITCHED TO THE STANDARD BARREL. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AND NO UNANTICIPATED X-RAYS TAKEN DURING THE PROCEDURE. CONCOMITANT DEVICES REPORTED: UNKNOWN HIP SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 135 DEG DHS PLATE-SHORT BARREL 4 HOLES/78MM-STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7207633 ↗
• InjuryJan 19, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A HIP PROCEDURE, ON AN UNKNOWN DATE IN (B)(6), THE SURGEON WAS UNABLE TO ENGAGE THE HIP SCREW USING A 135-DEGREE DYNAMIC HIP SCREW PLATE (2 HOLE WITH A SHORT BARREL). THE SURGEON ATTEMPTED TO ENGAGE THE HIP SCREW (X1) USING TWO SEPARATE SHORT BARREL PLATES WITHOUT SUCCESS AND SUBSEQUENTLY SWITCHED TO A STANDARD BARREL. THERE WAS A SLIGHT DELAY IN THE PROCEDURE DUE TO SWITCHING TO THE STANDARD BARREL PLATE. TO THE REPORTER¿S KNOWLEDGE, THERE WERE NO ADDITIONAL CONSEQUENCES. THE HIP SCREW AND THE STANDARD BARREL PLATE WERE SUCCESSFULLY IMPLANTED WITHOUT ANY FURTHER CONSEQUENCE TO THE PATIENT. THERE WAS AN ESTIMATED DELAY OF FIFTEEN (15) MINUTES WHILE THE SURGEON SWITCHED TO THE STANDARD BARREL. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AND NO UNANTICIPATED X-RAYS TAKEN DURING THE PROCEDURE. CONCOMITANT DEVICES REPORTED: UNKNOWN HIP SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 135 DEG DHS PLATE-SHORT BARREL 4 HOLES/78MM-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7207614 ↗