NA 208.890Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982150011), received between Sep 16, 2019 and Jan 4, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2022 PATIENT IN FOR PERC PIN FEMORAL HEAD SUBCAP FX. UPON PUTTING FIRST 7.3 CANN SCREWS IN ON POWER, XRAY SHOWED SCREW PERFORATED NEAR CORTEX, AND POWERED THRU ACETABULUM AND INTO NON BONE SPACE. BECAUSE FAR THREADS OR SCREW WERE IN NOTHING, THERE WAS NO PURCHASE TO BACK SCREW OUT. NO RESISTANCE. SCREW JUST SPUN. AFTER TRYING TO REMOVE/BRAINSTORMING OPTIONS APPROX 30MINS, SCREW REMAINED, AND DOCTOR DECIDED TO MOVE FORWARD WITH A NON SYNTHES BI POLAR HIP IMPLANT. THIS REPORT IS FOR ONE (1) 7.3MM CANNULATED SCREW 16MM THREAD/90MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096055 ↗
• InjuryApr 19, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO CUT-OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT¿S STATUS IS UNKNOWN. THIS REPORT INVOLVES (1) 7.3MM CANNULATED SCREW 16MM THREAD/90MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11687369 ↗
• InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO PROXIMAL FEMUR FRACTURE LOSS OF REDUCTION WITH DYNAMIC HIP SCREW SYSTEM (DHS) + CANNULATED SCREW AND WAS REVISED TO TOTAL HIP. THE PROCEDURE OUTCOME AND PATIENT'S STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 7.3MM CANNULATED SCREW 16MM THREAD/90MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10629158 ↗
• MalfunctionOct 16, 2019Break; Break

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND TO BE COVERED UNDER PERIODIC SUMMARY REPORTING AND NOT INDIVIDUAL 3500A REPORTING. THIS EVENT WILL BE CAPTURED ON THE PERIODIC SUMMARY REPORT.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9197637 ↗
• MalfunctionOct 16, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING A CLOSED REDUCTION PERCUTANEOUS FOR A PATIENT WITH A MINIMAL DISPLACED OF THE RIGHT FEMORAL NECK FRACTURE. THE CANNULATED SCREWS HAVE A SELF-TAPPING, SELF-DRILLING TIP AND THE DRILL TIP OF THE TWO (2) CANNULATED SCREW (SELF DRILLING) HAS SEPARATED FROM THE UNKNOWN DEVICE. WHILE INSERTING THE SCREW 2 OF THE 3 TIPS ON THE END OF THE SCREW FRACTURED. THE TIPS BROKE OFF ONE SCREW. THE SURGEON WAS NOT ABLE TO REMOVE THESE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE SURGEON REMOVED THE SCREW AND INSERTED ANOTHER SCREW. THERE WAS A SURGICAL DELAY OF FIFTEEN (15 MINUTES). PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT FOR 02 OF 02 OF (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9197632 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED THAT DURING A HIP PINNING PROCEDURE DUE TO A FEMORAL NECK FRACTURE ON (B)(6) 2019, TWO LITTLE TIPS OF THE CANNULATED SCREW WAS BROKEN OFF WHILE THE SCREW WAS BEING INSERTED INTO THE PATIENT. THE BROKEN PIECES WERE NOT RECOVERED AND WERE LEFT EMBEDDED IN THE PATIENT'S BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER CANNULATED SCREW. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT'S CONDITION IS UNKNOWN. THIS REPORT IS FOR A CANNULATED SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9072489 ↗