NA 03.100.045Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982070944), received between Oct 27, 2020 and Mar 10, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE FORCEPS TIP WAS BROKEN OFF. THE ELEVATOR WOODEN HANDLE WAS SNAPPED IN HALF. THE SCREWDRIVER TIP WAS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560397 ↗
• MalfunctionDec 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING THE PROCEDURE, IT WAS OBSERVED THAT ALL 2.5 MM DRILL BITS WERE DULL, AND ALL SCREWDRIVERS NO LONGER RETAINED THEIR HEXAGONAL SHAPE, PREVENTING THE CORRECT PLACEMENT OF THE SCREWS. THE PATIENT WAS NOT AFFECTED, BUT THERE WAS A DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788744 ↗
• MalfunctionMar 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE HOLDING SLEEVE 105MM HAS A CROSS THREADED NUT THAT IS STUCK AND SDDRIVE SCREWDRIVER SHAFT T15 250 LONG GETS STUCK IN QUICK CONNECT. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS UNKNOWN WHEN WAS THE EVENT OCCURRED. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SDDRIVE SCREWDRIVER SHAFT T15 250 LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462433 ↗
• MalfunctionSep 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SDDRIVE SCREWDRIVER SHAFT T15 250 LONG NOT FITTING PROPERLY IN DRIVER. IT WAS UNKNOWN WHEN WAS THE ISSUE OBSERVED. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SDDRIVE SCREWDRIVER SHAFT T15 250 LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15413289 ↗
• MalfunctionJun 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PELVIC SURGERY ON (B)(6) 2021, THE T-15 STARDRIVE SCREWDRIVER WILL NOT RETAIN THE PELVIC SCREWS AND THE SURGEONS HAVE INCREASED DIFFICULTY IN KEEPING THE DRIVERS ENGAGED TO THE SCREWS AS THEY INSERT THE SCREWS. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977580 ↗
• MalfunctionJun 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PELVIC SURGERY ON (B)(6) 2021, THE T-15 STARDRIVE SCREWDRIVER WILL NOT RETAIN THE PELVIC SCREWS AND THE SURGEONS HAVE INCREASED DIFFICULTY IN KEEPING THE DRIVERS ENGAGED TO THE SCREWS AS THEY INSERT THE SCREWS. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977527 ↗
• MalfunctionJan 22, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217544 ↗
• MalfunctionJan 22, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217534 ↗
• MalfunctionNov 11, 2020Break; Break

  IT WAS REPORTED THAT WHILE INSPECTING BACK UP ITEMS ON AN UNKNOWN DATE, SOME WERE SET ASIDE FOR COMPLAINTS. 1 STARDRIVE SCREWDRIVER TEETH ARE CHIPPED. 2DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HAD WIRES LOOSE. 1 STARDRIVE SHAFT TEETH WAS CHIPPED. AND 1INTERLOCKING SCREWDRIVER IS WARPED AND SHIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10825434 ↗
• MalfunctionOct 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4 STARDRIVE SCREWDRIVER SHAFTS WERE DAMAGED. THE STARDRIVE SHAFTS WOULD NOT LOAD INTO A STANDARD AO QUICK CONNECT CHUCK ON THE DRILL, SEVERAL CHUCKS AND VARIATIONS WERE TRIED. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN AO QUICK CONNECT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR 1 STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10740640 ↗
• MalfunctionOct 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4 STARDRIVE SCREWDRIVER SHAFTS WERE DAMAGED. THE STARDRIVE SHAFTS WOULD NOT LOAD INTO A STANDARD AO QUICK CONNECT CHUCK ON THE DRILL, SEVERAL CHUCKS AND VARIATIONS WERE TRIED. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN AO QUICK CONNECT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR 1 STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10740614 ↗
• MalfunctionOct 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FOUR (4) STARDRIVE SCREWDRIVER SHAFTS WERE DAMAGED. THE STARDRIVE SHAFTS WOULD NOT LOAD INTO A STANDARD AO QUICK CONNECT CHUCK ON THE DRILL, SEVERAL CHUCKS AND VARIATIONS WERE TRIED. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN AO QUICK CONNECT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10739998 ↗
• MalfunctionOct 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4 STARDRIVE SCREWDRIVER SHAFTS WERE DAMAGED. THE STARDRIVE SHAFTS WOULD NOT LOAD INTO A STANDARD AO QUICK CONNECT CHUCK ON THE DRILL, SEVERAL CHUCKS AND VARIATIONS WERE TRIED. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN AO QUICK CONNECT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR 1 STARDRIVE SCREWDRIVER SHAFT 250MM LONG. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10739995 ↗