NA 03.019.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982069597), received between Aug 14, 2019 and Jul 23, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER WAS ROUNDED OFF. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580170 ↗
• MalfunctionSep 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) ON (B)(6), 2023, FOR FRACTURE OF PROXIMAL HUMERUS WITH STARDRIVE SCREWDRIVER AND MULTILOC HUMERAL NAIL AND ENDCAP. THE SURGERY PROCEEDED SMOOTHLY, BUT IT BECAME DIFFICULT TO INSERT THE END CAP AT THE STAGE OF INSERTING IT. THE NAIL WAS SLIGHTLY OVER-INSERTED, SO THE SURGEON OPTED FOR A 2MM ENDCAP, WHICH COULD NOT BE INSERTED. THE SURGEON VERIFIED THE ORIENTATION OF THE DRIVER FROM VARIOUS ANGLES, AND ATTEMPTED TO REFASTEN IT, BUT WAS UNABLE TO INSERT IT. THE SURGEON WAS CONCERNED THAT THE ENDCAP WOULD COME OFF, SO TRIED TO REMOVE IT. HOWEVER, THE END CAP WAS STUCK BETWEEN THE HEAD SUBCHONDRAL BONE AND THE NAIL AND COULD NOT BE PULLED OUT. EVENTUALLY, THE SURGEON MANAGED TO EXTRACT IT. THE SURGEON AGAIN TRIED TO PLACE THE ENDCAP AGAIN. AGAIN, IT BECAME DIFFICULT TO INSERT, BUT AFTER SEVERAL ATTEMPTS, THE SURGEON WAS FINALLY ABLE TO INSERT THE END CAP FIRMLY. THE SURGEON BELIEVES THAT THERE WAS A POSSIBILITY THAT SOMETHING WAS INTERPOSED BETWEEN THE END CAP AND THE NAIL, OR THAT THE CENTER OF THE ENTRY HOLE AND THE NAIL, WHICH SHOULD HAVE BEEN COAXIAL,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825045 ↗
• MalfunctionSep 12, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POST-OP EVENT THE SCREWDRIVER APPEARED TO BE STRIPPED AND TIP OF DEPTH GAUGE HAD BEEN BROKEN OFF AFTER DECONTAMINATION PROCESS. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE STARDRIVE SCREWDRIVER T25 W/ COUPLING FOR 03.019.019/330MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406288 ↗
• MalfunctionDec 7, 2020Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR PROXIMAL HUMERUS FRACTURE. DURING THE SURGERY, THE SURGEON HAD A DIFFICULTY INSERTING THE ENDCAP. THE SURGEON REMOVED THE ENDCAP AND WHEN THE NURSE WIPED OFF THE BLOOD ON THE ENDCAP WITH THE GAUZE, AN UNKNOWN SMALL METALLIC FRAGMENT STUCK IN NURSE¿S HAND. THE SURGEON STOPPED USING THE ENDCAP AND SCREWDRIVER BECAUSE IT IS POSSIBLE THAT THEY HAD SOME PROBLEM AND THEY BECAME CONTAMINATED. THE SURGEON CLOSED THE INCISION WITHOUT THE ENDCAP INSERTION AND THE SURGERY WAS COMPLETED WITHIN THIRTY (30) MINUTES DELAY. THE NURSE WAS CHECKED BY A BLOOD TEST. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: CASQUILLO-CIERRE MULTILOC P/HN/PHN MULTI (PART # 04.019.002S, LOT # 50P4537, QUANTITY 1). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T25 W/ COUPLING FOR 03.019.019/330MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962174 ↗
• MalfunctionFeb 13, 2020Material Twisted/Bent; Material Twisted/Bent

  PATIENT'S OUTCOME IS REPORTED AS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707852 ↗
• MalfunctionJan 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR PROXIMAL HUMERUS FRACTURE WITH THE LOCKING SCREW AND THE STARDRIVE SCREWDRIVER IN QUESTION. DURING THE SURGERY, THE SURGEON REPLACED A LOCKING SCREW (20MM) WITH THE SCREW (22MM) BECAUSE THE 20MM SCREW WAS SHORT. THE SCREW DIDN¿T SEEM TO STICK IN THE BONE FIRMLY SO THE SURGEON PUSHED THE SCREW WITH THE SCREWDRIVER, BUT THE SCREW BACKED OUT WITH THE SCREWDRIVER. THERE WAS NO SURGICAL DELAY. THE SURGEON COMMENTED THAT THE BONE QUALITY MIGHT BE BAD. THIS REPORT IS FOR ONE STARDRIVE SCREWDRIVER T25 W/ COUPLING FOR 03.019.019/330MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9577255 ↗
• InjuryAug 14, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR LEFT HUMERUS SHAFT FRACTURE WITH MULTILOC HUMERAL NAILING SYSTEM. DURING SCREW INSERTION TO THE SECOND DISTAL HOLE, THE SCREW COULD NOT BE INSERTED FURTHER WHEN IT REACHED THE CONTRALATERAL BONE AND THE SCREWDRIVER SLIPPED. THE SURGEON TRIED TO INSERT SCREWS INTO ANOTHER HOLE, BUT THE SCREWS COULD NOT BE INSERTED. THE SURGERY WAS DELAYED BY FORTY-FIVE (45) MINUTES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8893297 ↗