NA 03.226.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10886982077042), received between Dec 22, 2016 and Mar 19, 2026 — classified as 1 injury, 63 malfunctions.

The most frequently reported specific device problem is “Break” (57 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT THE SCRDRIVER SHAFT CANN T8 W/COLOUR-MARKING WAS BROKEN AT ONE OF THE EDGES DURING A PROCEDURE. THE DEVICE SEPARATED INTO TWO OR MORE PIECES INTRAOPERATIVELY. THE BROKEN PIECE WAS PROMPTLY REPLACED WITH ANOTHER OF THE SAME CHARACTERISTICS, ALLOWING THE SURGERY TO BE COMPLETED SUCCESSFULLY WITHOUT DISCOMFORT FOR THE SPECIALIST, WITHOUT AFFECTING THE PATIENT, AND WITHOUT ALTERATIONS IN SURGICAL TIMES. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641564 ↗
• MalfunctionJan 30, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THE TIP OF THE SCREWDRIVER SHAFT WAS DAMAGED AND WON¿T FIT INTO THE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223534 ↗
• MalfunctionJul 14, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496562 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPERATION TO TREAT LEFT PATELLA FRACTURE. SURGEON PLANNED TO INSERT 2 HEADLESS COMPRESSION SCREWS IN PARALLEL MANNER ACROSS FRACTURE SITE. IT WAS DIFFICULT TRAJECTORY. THE FIRST GUIDE WIRE WAS INSERTED WITHOUT ISSUE. SECOND GUIDE WIRE WAS INSERTED IN A CONVERGENT MANNER AND IMPACTED TO THE FIRST GUIDE WIRE, RESULTED IN BREAKAGE OF THE TIP OF THE SECOND GUIDE WIRE WITHIN BONE. SURGEON DECIDED NOT TO REMOVE IT. A CANNULATED DRILL BIT TIP WAS INSERTED OVER THE GUIDE WIRE AND REAMING WAS DONE. HOWEVER, THE TIP WAS BROKEN OFF WITHIN BONE PROBABLY ALSO DUE TO THE DIFFICULT TRAJECTORY. IT WAS ALSO DECIDED NOT TO REMOVE. THE CANNULATED SCREWDRIVER WAS USED TO INSERT THE HEADLESS COMPRESSION SCREW, THE SCREW DRIVER'S TIP BROKE OUTSIDE THE BONE AND WAS ABLE TO BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340872 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE THE DOCTOR WAS SCREWING, THE TIP OF THE T SCREWDRIVER WITH COLOR MARKING BROKE. A PROMPT SOLUTION WAS FOUND TO HANDLE THE SITUATION BY USING ANOTHER SCREWDRIVER, THUS COMPLETING THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT, WITHOUT DISCOMFORT TO THE SPECIALIST, AND WITHOUT ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900045 ↗
• MalfunctionFeb 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOW DATE IT WAS FOUND IN THE STERILE PROCESSING DEPARTMENT THAT THE CANN SD SCRWDRVR SFT FOR 3.0 HCS T8 WAS FOUND TO BE STRIPPED. REPLACEMENT IS NEEDED. THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21435944 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, HCS1.5 DRILL BIT WAS NOT USED BECAUSE IT SEEMED TO BE BENT, AND THE SCREWDRIVER WAS DEFORMED AND COULD NOT CONNECT TO THE SCREW IN QUESTION. DUE TO THE ABOVE TROUBLE, THE SURGEON SWITCHED TO USING 2.4. HOWEVER, THE TIP OF THE SCREWDRIVER WAS BROKEN OFF. SINCE THE HOSPITAL HAS HCS 2.4 INSTRUMENTS ON CONSIGNMENT, THE INSTRUMENTS WERE OPENED AND THE SURGEON USED THEIR SCREWDRIVER TIPS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THE SURGEON COMMENTED THAT THE DRILL MAY HAVE BEEN DEFORMED FROM THE TIME OF SHIPMENT, AND HE DIDN'T APPLY SO MUCH STRANGE FORCE WHEN USING THE BROKEN SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844731 ↗
• MalfunctionSep 11, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE DEVICE IS RUPTURED. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20194228 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEM HAD A BROKE TIP. THIS WAS NOTICED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8 THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709181 ↗
• MalfunctionJul 9, 2024Degraded; Degraded

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, WHEN THE BONE IS BEING DRILLED, THE DRILL BIT BROKE, LEAVING A PART OF THE DRILL BIT IN THE PATIENT, WHICH DOES NOT AFFECT THE PATIENT. AT THE TIME OF FINISHING SCREWING THE FIRST SCREW WHEN THE SPECIALIST HANDED THE SCREWDRIVER IT WAS OBSERVED THAT THERE IS A BREAKDOWN IN THE PAINT. THERE WERE NO COMPLICATIONS IN THE SURGERY AND IT WAS FINISHED WITHOUT DIFFICULTY. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19701767 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, A CANN SD SCRWDRVR SFT FOR 3.0 HCS T8 WAS DAMAGED. THE TIP OF THE POWER SHAFT WAS BROKEN OFF. THIS REPORT IS FOR A CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18518453 ↗
• MalfunctionJan 9, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE A DRILL BIT WITHOUT EDGE AND A SCREWDRIVER TIP DETERIORATED WERE FOUND. IT IS NOT KNOWN WHEN THE MALFUNCTION OCCURRED. THIS REPORT IS FOR CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18478946 ↗
• MalfunctionDec 26, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY WITH THE SCREWDRIVER SHAFT IN QUESTION FOR THE CALCANEUS. EXTRACTION WAS PERFORMED BECAUSE BONE FUSION WAS ACHIEVED. DURING EXTRACTION OF TWO SCREWS, THE SCREWDRIVER SHAFT BROKE. ANOTHER SCREWDRIVER SHAFT FOR ANOTHER SURGERY WAS USED; HOWEVER, ONE OF THE SCREWS COULD NOT BE REMOVED. THE OPERATION TIME WAS EXTENDED BY ABOUT 40 MINUTES FOR STERILIZATION OF THE REPLACEMENT DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON NOTED THAT THE SCREW APPEARED SLIGHTLY BENT ON THE X-RAY, AND SUSPECTED THAT THIS MIGHT HAVE CAUSED THE SCREW TO BE STIFFER THAN USUAL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18394560 ↗
• MalfunctionDec 21, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE WHILE USING INTRAOPERATIVELY ON NOVEMBER 27, 2023. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375655 ↗
• MalfunctionSep 13, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS IN TRAY WERE FOUND TO BE BROKEN POST DECONTAMINATION. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANN SD SCRWDRVR SFT FOR 3.0 HCS T8. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736882 ↗
• MalfunctionSep 13, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS IN TRAY WERE FOUND TO BE BROKEN POST DECONTAMINATION. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANN SD SCRWDRVR SFT FOR 3.0 HCS T8 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736838 ↗
• MalfunctionAug 7, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS FURTHER CLARIFIED THE DEVICE DID NOT BREAK. THE DEVICE DID NOT FUNCTION DUE TO WEAR. ACCORDING TO THE FACILITY THE DEVICE HAD BEEN EXHAUSTED AFTER VARIOUS INTENSIVE USES AND NO LONGER HAS THE NECESSARY GRIP. THE DEVICE WAS DISPOSED OF. NO OPERATION HAD TO BE MOVED OR ABORTED AND NO PATIENT HAS BEEN INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469720 ↗
• MalfunctionMar 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, PRE-OPERATIVELY THE CUSTOMER HAS CONFIRMED THAT THE DEVICE WAS BROKEN BECAUSE IT WAS WORN OUT. THEY USE SCREWDRIVERS WITH HIGH FREQUENCY, THEREFORE THE DEVICE HAS UNDERGONE MANY CYCLES OF STERILIZATION. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592939 ↗
• MalfunctionMar 7, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE DEVICE BROKE AT THE TIME OF INSERTING THE SCREW. IT DID NOT AFFECT THE PATIENT. IT WAS POSSIBLE TO REMOVE THE OTHER PART. THIS REPORT INVOLVES ONE CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496832 ↗
• MalfunctionFeb 10, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY WITH THE SCREWDRIVER SHAFT IN QUESTION. DURING THE SURGERY, THE SCREWDRIVER SHAFT BROKE. REMOVING WAS PERFORMED IN SOME WAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS IS AN INFECTION CASE, SO THAT THE DEVICES WILL BE DISCARDED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT CANN T8 W/COLOUR-MARKING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16351290 ↗
• MalfunctionJan 10, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT IN QUESTION HAS ARRIVED BROKEN PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT CANN T8 W/COLOUR-MARKING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16130489 ↗
• MalfunctionDec 6, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: WHEN USING THE SCREWDRIVER TO PLACE A SCREW, WHEN TURNING IT INSIDE THE SCREW HEAD, IT BROKE, IT DID NOT CAUSE REPERCUSSIONS ON THE PATIENT BECAUSE IT WAS DONE WITH ANOTHER PIECE OF SCREWDRIVER THAT WAS IN THE KIT. IT IS MARKED WITH RED TAPE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT CANN T8 W/COLOUR-MARKING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924167 ↗
• MalfunctionSep 7, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER TIP BROKE OFF DURING A SURGICAL CASE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SLIGHT DELAY. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CANNULATED STARDRIVE SCREWDRIVER SHAFT FOR 3.0MM HCS T8. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370740 ↗
• MalfunctionMar 1, 2022Break; Break

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, A SCREWDRIVER BELONGING TO THE HCS 2.4MM SET BROKE. ALL SMALL FRAGMENTS FROM THE SCREWDRIVER WERE RETRIEVED FROM THE SURGICAL SITE. THE SURGEON USED A NON-CANNULATED SCREWDRIVER TO FINISH THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH APPROXIMATELY TWENTY MINUTES DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8.THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636562 ↗
• MalfunctionFeb 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE SHAFT TIP WAS FOUND SHEARED OFF. THE BROKEN PART WAS EASILY IDENTIFIED AND REMOVED. NO HARM TO PATIENT AND MINIMAL DELAYS WERE CAUSED. BROKEN PART WAS DISPOSED AND INSTRUMENT WILL BE TO BE SENT BACK. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT CANN T8 W/COLOUR-MARKING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13484111 ↗