NA 314.468Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10886982188939), received between Dec 31, 2018 and Apr 21, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE HOLDING SLEEVE DOES NOT PROPERLY HOLD SCREWS. ITEM SCREWDRIVER SLEEVE IS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938170 ↗
• MalfunctionMay 14, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE HOLD-SL F/SCR 2.4 T8 F/SCREWDRIVER S CONSISTS OF 4 PARTS, AND IS MISSING THE SPRING BELONGING TO IT. THE PRODUCT DAMAGE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020156 ↗
• MalfunctionJul 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY WITH THE HOLDING SLEEVE. THE SURGEON NOTED THAT THE HOLDING SLEEVE WAS WEAK IN GRASPING THE 2.7MM LOCKING SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413294 ↗
• MalfunctionJul 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT BEFORE SURGERY ON (B)(6) 2023, IT WAS FOUND THAT THE SLEEVE WAS UNABLE TO BE ENGAGED WITH THE SCREWDRIVER. ANOTHER DEVICE WAS USED FOR THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371304 ↗
• MalfunctionJul 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON MAY 25, 2023, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR DISTAL HUMERAL FRACTURE WITH SCREWDRIVER SHAFT AND HOLDING SLEEVE. DURING THE SURGERY, THE 2.7 MM SCREW COULD NOT BE ATTACHED TO THE SCREWDRIVER SHAFT AND THE HOLDING SLEEVE COULD NOT BE ATTACHED FIRMLY, MAKING SCREW INSERTION DIFFICULT. AFTER THE SURGERY, THE SURGEON EXAMINED A T9 SCREWDRIVER PROVED TO BE A FIRMER FIT THAN THE T8 SCREWDRIVER, AND THE SURGEON WONDERED IF THE STANDARD OF THE T8 SCREWDRIVER WAS CORRECT. ON JUNE 28, 2023, THE PERSON IN CHARGE BROUGHT A DEMO IMPLANT AND DEMO INSTRUMENT AND CONFIRMED WITH THE SURGEON THAT IT COULD BE ATTACHED WITH A SCREW WITH A SCREWDRIVER SHAFT. THE REPRESENTATIVE ALSO EXPLAINED TO THE SURGEON THAT NO T9 STANDARD EXISTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES DELAY. THE SURGEON COMMENTED THAT THERE WAS NO PROBLEM WITH THE BONE FIXATION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364049 ↗
• MalfunctionJul 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2023, THE SURGEON COMPLAINED THAT A RETAINING SLEEVE WAS "HIT OR MISS" WHEN IT CAME TO HOLDING THE SCREW AND SOMETIMES WAS STRIPPING SCREWS. ADDITIONALLY, A VA LOCKING SCREW WAS BENT, AND WAS REMOVED AND REPLACED WITH ANOTHER SCREW INTRA-OPERATIVELY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE; THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 2 FOR PC: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265890 ↗
• MalfunctionApr 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE BONE FRACTURE OF DISTAL END OF HUMERUS ON (B)(6) 2022, THE HOLDING SLEEVE DEVICE WAS USED TO GRASP A 2.7 MM SCREW, BUT THE SCREW COULD NOT BE GRASPED NORMALLY DUE TO LOOSENESS. AFTER THAT, ALL SCREWS REGARDLESS OF THE LENGTH COULD NOT BE GRIPPED PROPERTY BY THE HOLDING SLEEVE DEVICE. IT WAS CONFIRMED THAT THERE WAS NO LOOSENING IN THE HOLDING SLEEVE ITSELF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) HOLD-SL F/SCR Ø2.4 T8 F/SCRDRIVER SHAFTS DEVICE. THIS COMPLAINT INVOLVES 2 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14173878 ↗
• MalfunctionMar 21, 2022Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FIELD STOCKING LOCATION(FSL) (B)(4), IT WAS OBSERVED THAT HOLDING SLEEVE FOR SD SCREWDRIVER SFT T8 WAS MISSING A COMPONENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICES HOLDING SLEEVE FOR SD SCREWDRIVER SFT T8. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840101 ↗
• MalfunctionMar 14, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE HOLDING SLEEVE FOR SCREWS STARDRIVE WAS OBSERVED MISSING A COMPONENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13760037 ↗
• MalfunctionNov 23, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR SD SCREWDRIVER SFT T8 WAS MISSING A COMPONENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860299 ↗
• MalfunctionNov 4, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS LYNDHURST, NJ SITE, IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR SCREWDRIVER WAS MISSING A COMPONENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE FOR SD SCREWDRIVER SFT T8. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12753892 ↗
• MalfunctionSep 29, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, SPRING HAS BEEN MISPLACED. THIS REPORT IS FOR (1) HOLDING SLEEVE FOR SD SCREWDRIVER SFT T8. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548661 ↗
• MalfunctionAug 26, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF THE LOANER SET, IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR SCREWDRIVER WAS MISSING A COMPONENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375034 ↗
• MalfunctionJul 27, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR SD SCREWDRIVER SHAFT T8 WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12226230 ↗
• MalfunctionFeb 11, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FIELD STOCKING LOCATION (FSL) IT WAS OBSERVED THAT THE HOLDING SLEEVE WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS COMPLAINT IS FOR ONE (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8 THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313573 ↗
• MalfunctionDec 29, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION AT A LOANER SET, IT WAS OBSERVED THAT THE HOLDING SLEEVE WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089559 ↗
• MalfunctionAug 7, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A HOLDING SLEEVE WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379729 ↗
• MalfunctionJul 27, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN INSPECTION, THE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT AND THE HOLDING SLEEVE FOR CANNULATED SCREWDRIVER WOULD NOT SPRING BACK INTO PLACE. THE CANNULATED AWL HAD PITTING AND DENTS ON THE BLADE. THERE WAS NO PATIENT INVOLVEMENT. DETERMINED TO BE A REPORTABLE MALFUNCTION ON (B)(6) 2020. THIS REPORT INVOLVES ONE (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10326103 ↗
• MalfunctionMay 27, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF THE LOANER SET AT FSL OWENS & MINOR HOUSTON, TX SITE, IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT WAS MISSING A PIECE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092395 ↗
• MalfunctionMar 27, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8 WAS MISSING INTERNAL PIECES. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT INVOLVES ONE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889837 ↗
• MalfunctionMar 6, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, THE HOLDING SLEEVE WAS STICKING ON THE SHAFT OF THE SCREWDRIVER INTRAOPERATIVELY. THERE WAS NO PATIENT HARM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9801331 ↗
• MalfunctionJan 27, 2020Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING LOAN KIT INSPECTION THE SPRING CAME OUT OF THE SCREWDRIVER SHAFT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9632414 ↗
• MalfunctionJan 7, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF LOANER SET IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT WAS MISSING A PIECE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557706 ↗
• MalfunctionJan 6, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT WAS MISSING A PIECE. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9554892 ↗
• MalfunctionDec 9, 2019Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT WAS MISSING A PIECE. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9439924 ↗