NA 03.240.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982077523), received between Nov 14, 2017 and Apr 18, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN AND TWISTED TIP. THIS REPORT IS FOR ONE CANNULATED SD SCREWDRIVER SHAFT/T15 FOR PC-001576833

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133296 ↗
• MalfunctionJun 13, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SET INSPECTIONS ON (B)(6) 2023, THE DRIVER IN QUESTION WAS FOUND TO BE BENT. THERE WAS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121112 ↗
• MalfunctionSep 28, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE BELOW ITEMS WERE FOUND TO BE DAMAGED IN SPD AT THE HOSPITAL. T15 CANNULATED SCREW DRIVER HAD TWISTED TIP. 2.0/2.4MM DEPTH GAUGE TIP WAS BROKEN. 4MM HEX CANNULATED SCREW DRIVER HAD A DEFECT IN THE RUBBER OF THE HANDLE. THE ITEMS WERE SET ASIDE IN SPD OF THE HOSPITAL FOR REPAIR/REPLACE. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499192 ↗
• MalfunctionJul 29, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT WAS FOUND STRIPPED IN THE SET, AFTER THE SET WAS RETURNED TO OFFICE. THERE WERE NO PATIENT OUTCOMES/CONSEQUENCES REPORTED. THIS REPORT INVOLVES ONE (1) CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128349 ↗
• MalfunctionMar 3, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022 THE SET WAS RETURNED TO OFFICE WITH A TORQUED SCREWDRIVER SHAFT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE CANNULATED SD SCREWDRIVER SHAFT/T15. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13661282 ↗
• MalfunctionDec 9, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT FOLLOWING WASH ON AN UNKNOWN DATE, SEVERAL PRODUCTS WERE FOUND TO BE FAULTY. UPON MANUFACTURER INVESTIGATION, THE DEVICE WAS DISCOVERED TO BE TWISTED/STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12970687 ↗
• MalfunctionApr 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS FOUND OUT THAT THE TIPS OF THE TWO CANNULATED STARDRIVE SCREWDRIVER T15 SCREWDRIVERS WERE BENT. NO PATIENT CONSEQUENCE. PATIENT OUTCOME WAS GOOD. UPON VISUAL INSPECTION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DISTAL TIP (DRIVE FEATURE) OF THE DEVICE WAS TWISTED, NOT BENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688634 ↗
• MalfunctionJun 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A CANNULATED STARDRIVE SCREWDRIVER SHAFT WAS TWISTED. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR 1 CANNULATED STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10136177 ↗
• MalfunctionMay 19, 2020Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2020, IT WAS REPORTED THAT THE CANNULATED STARDRIVE SCREWDRIVER SHAFT WAS TWISTED. IT IS ALSO UNKNOWN WHEN THE ISSUE WAS DISCOVERED OR IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10070805 ↗
• MalfunctionApr 13, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON MARCH 16, 2020, TWO (2) CANNULATED STARDRIVE SCREWDRIVERS WERE TWISTED AND STRIPPED; THE ENDS OF IT ARE TWISTED WHERE IT WOULD CONTACT A SCREW. ONE (1) LOCKING PLIERS-LONG WAS DAMAGED AND WOULD NOT GRIP ONTO THE ITEM TRYING TO BE REMOVED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9953119 ↗
• MalfunctionApr 13, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, TWO (2) CANNULATED STARDRIVE SCREWDRIVERS WERE TWISTED AND STRIPPED; THE ENDS OF IT ARE TWISTED WHERE IT WOULD CONTACT A SCREW. ONE (1) LOCKING PLIERS-LONG WAS DAMAGED AND WOULD NOT GRIP ONTO THE ITEM TRYING TO BE REMOVED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9953112 ↗
• MalfunctionMay 2, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON THE EVENING OF MARCH 12, 2019, THE SALES CONSULTANT CONTACTED FIELD STOCKING LOCATION TO SAY THAT THE CANNULATED STARDRIVE SCREWDRIVER SHAFT ON SET FE45498 WAS BENT. THE SET WAS TO BE USED IN SURGERY ON MARCH 13, 2019. THE REPLACEMENT SET WAS SENT PRIOR TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER SHAFT/T15 THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8574874 ↗
• MalfunctionApr 3, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT PROXIMAL HUMERUS ON (B)(6) 2018, THREE (3) SEPARATE CANNULATED STARDRIVE SCREWDRIVER SHAFTS BECAME TWISTED AND WOULD NOT PROPERLY SEAT IN THE SCREW RECESS. SURGERY WAS COMPLETED WITH NO DELAY. PATIENT OUTCOME REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393108 ↗
• MalfunctionApr 3, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT PROXIMAL HUMERUS ON (B)(6) 2018, THREE (3) SEPARATE CANNULATED STARDRIVE SCREWDRIVER SHAFTS BECAME TWISTED AND WOULD NOT PROPERLY SEAT IN THE SCREW RECESS. SURGERY WAS COMPLETED WITH NO DELAY. PATIENT OUTCOME REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER SHAFT. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393083 ↗
• MalfunctionApr 3, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT PROXIMAL HUMERUS ON (B)(6) 2018, THREE (3) SEPARATE CANNULATED STARDRIVE SCREWDRIVER SHAFTS BECAME TWISTED AND WOULD NOT PROPERLY SEAT IN THE SCREW RECESS. SURGERY WAS COMPLETED WITH NO DELAY. PATIENT OUTCOME REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER SHAFT. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393051 ↗
• MalfunctionNov 14, 2017Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE TIPS ARE STRIPPED ON ONE CANNULATED SCREWDRIVER AND ONE CANNULATED SCREWDRIVER SHAFT. THIS WAS DISCOVERED DURING ROUTINE INSPECTION OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICES HAVE BEEN USED BEFORE AND ARE APPROXIMATELY 6 YEARS OLD. THERE WAS NO UNUSUAL USE OF DEVICES AND THEY HAD BEEN USED AS INTENDED. THERE WAS NO DAMAGE NOTED ON THE MATING INSTRUMENTS PRIOR TO THIS COMPLAINT. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7029052 ↗