NA 03.505.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587013336), received between Aug 13, 2019 and Aug 5, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 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.

• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145386 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145380 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145373 ↗
• InjuryJun 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT A RE-OPEN SURGERY FOR THE REMOVAL OF REMAINED FOREIGN OBJECT. INITIALLY ON (B)(6) 2021, THE PATIENT UNDERWENT A RIB PLATING AND OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE TO TREAT ULNAR FRACTURE FROM A MOTOR VEHICLE ACCIDENT. DURING THE PROCEDURE THE DEVICE USED TO SECURE SCREWS CAME APART VS FAILED AT THE END OF THE PROCEDURE. X-RAY TAKEN AFTER CLOSURE OF PROCEDURE SHOWED A SIGNIFICANT FOREIGN OBJECT IN SUBCUTANEOUS TISSUE. PATIENT WAS NOT REMOVED FROM THE OPERATING ROOM AND WAS NOT EXTUBATED FROM THE INITIAL PROCEDURE. THIS REPORT CAPTURES THE RE-OPENING OF THE PATIENT FOR THE REMOVAL OF THE FOREIGN BODY OBJECT POST-OPERATIVELY, WHILE RELATED COMPLAINT (B)(4) (MW5100352) CAPTURES THE INTRA-OP EVENT WHERE THE DEVICE USED TO SECURE SCREWS CAME APART VS FAILED AT THE END OF THE RIB PLATING PROCEDURE. THIS REPORT IS FOR ONE (1) GEAR COVER FOR SCREWDRIVER 90. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 11923990 ↗
• InjuryJun 2, 2021Break; Break

  RIB PLATING WAS SUCCESSFULLY COMPLETED. THERE WAS A DELAY OF AN UNKNOWN LENGTH WHILE THE PATIENT WAS REOPENED TO RETRIEVE THE ITEM. THE ORIF FOR ULNAR FRACTURE WAS ALSO SUCCESSFULLY COMPLETED WITH NO ISSUES. IT WAS NOTED THE POST-OPERATIVE COURSE WAS UNCOMPLICATED AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11921006 ↗
• MalfunctionAug 13, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN OPEN REDUCTION INTERNAL FIXATION TO THE RIGHT RIBS, THE GEAR FOR SCREWDRIVER POPPED OUT OF THE BACKSIDE OF THE SHAFT HEAD WHEN PRESSURE WAS APPLIED TO THE SCREWDRIVER BLADE. 90¿ WAS BEING USED TO SCREW IN A 12 MM SCREW DURING THE PROCEDURE. WHEN ANALYZED THE GEAR ITSELF SEEMED TO BE TORN UP FROM INNER SHAFT ENGAGING THE THREADS. THE GEAR WAS THEN REINSERTED AND THE CAP WAS TIGHTENED ONTO THE SHAFT AGAIN. ONCE REPAIRED, PRESSURE WAS AGAIN APPLIED AND THE GEAR POPPED OUT OF THE BACKSIDE AGAIN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 15 MINUTES OF SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN 12 MM SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY# 1), UNKNOWN SCREWDRIVER BLADE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY# 1), UNKNOWN SHAFT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 8889753 ↗