NA 03.019.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982069429), received between Mar 28, 2019 and Feb 23, 2026 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT DURING INSPECTION OF THE MULTILOCK HUMERAL NAILING SYSTEM, IT WAS NOTICED THAT SCREWDRIVER HANDLE WOULD NOT CONNECT TO THE SCREWDRIVER SHAFT. THIS ITEM WAS NOT USED IN A PROCEDURE, BUT WAS DISCOVERED DURING ROUTINE INSPECTION OF INSTRUMENTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416009 ↗
• MalfunctionJan 26, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN ORIF FOR LEFT PROXIMAL HUMERUS FRACTURE WITH THE HANDLE. DURING THE SURGERY, WHEN THE SURGEON TRIED TO ASSEMBLE A SCREWDRIVER PRIOR TO A SCREW-IN-SCREW PROCEDURE, THE TORQUE LIMITATION ATTACHMENT AND SCREWDRIVER TIP WERE ATTACHED TO THE RELEVANT ITEM, BUT THEY CAME OFF WHEN PULLED. THIS WAS RESOLVED BY USING A SUBSTITUTE DRIVER HANDLE AVAILABLE AT THE HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24181267 ↗
• MalfunctionJun 15, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, INSIDE THE INSTRUMENT´S QUICK COUPLING MECHANISM A SURFACE CHANGE IS VISIBLE. DUE TO INACCESSIBILITY OF THIS PART OF THE INSTRUMENT THE CUSTOMER IS NOT WILLING TO USE THE INSTRUMENT WHICH IS PART OF A SHORT-TERM LOANER KIT / ORTHOKIT. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE (1) HANDLE WITH QUICK COUPLING LENGTH 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14696985 ↗
• MalfunctionAug 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE HANDLE WOULD NOT HOLD THE SCREWDRIVER WITH AO QUICK COUPLING IN PLACE. A SIMILAR DEVICE WAS USED INSTEAD. PROCEDURE WAS COMPLETED WITH NO DELAY. THIS REPORT IS FOR A HANDLE WITH QUICK-COUPLING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459630 ↗
• MalfunctionMar 28, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ROUTINE INCOMING INSPECTION OF LOANER SET, IT WAS OBSERVED THAT HANDLE WITH QUICK COUPLING WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8461438 ↗