NA 314.118Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982188557), received between Dec 14, 2017 and Sep 15, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Break” (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Crack; Material Twisted/Bent; Illegible Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780282 ↗
• MalfunctionJul 27, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038702 ↗
• MalfunctionMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREOP TESTING/ INSPECTION IT WAS FOUND THAT THE ITEM IS NO LONGER FUNCTIONAL, SHAFT PULLS OUT OF HANDLE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559296 ↗
• MalfunctionJan 30, 2026Device-Device Incompatibility; Material Deformation; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER A CASE IT WAS NOTICED THAT THE HEAD OF THE SCREWDRIVER IS BENT AND IT IS CAUSING THE SCREWS TO GET STUCK ON THE END. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225744 ↗
• MalfunctionAug 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, REP NOTICED THAT THERE WERE SOME THAT WERE DAMAGED. REP DOES NOT KNOW WHEN THIS DAMAGE OCCURRED WHETHER IT WAS POSTOP OR PREOP. THERE WAS NO PATIENT INVOLVEMENT. SOME OF THE INSTRUMENTS HAVE TO BE ABLE TO SEND BACK, BUT THERE ARE A COUPLE THAT WILL NOT BE ABLE TO RETURN BECAUSE THEY WERE DISPOSED OF BY THE FACILITY. REP KNOWS THE LOT NUMBER ON SOME OF THEM, BUT THE ONES THAT WERE DISPOSED OF REP DOES NOT KNOW THE LOT NUMBER. 1. PRODUCT # 314.118, LOT # H887026, QUANTITY 1. THIS ITEM IS A T25 SCREWDRIVER, AND THE TIP OF THE SCREWDRIVER IS STRIPPED. THIS ITEM IS AVAILABLE FOR RETURN. 2. PRODUCT # 03.127.010, LOT # 8391544, QUANTITY 1. THIS ITEM IS A DRILL SLEEVE FOR AN AIMING ARM, AND THE TIP OF IT IS BENT AND NEEDS REPLACED. THIS ITEM IS AVAILABLE FOR RETURN. 3. PRODUCT # 319.006, LOT # H873105, QUANTITY 1. THIS ITEM IS A DEPTH GAUGE, AND THE TIP OF THE DEPTH GAUGE IS BROKE OFF. THIS ITEM IS AVAILABLE FOR RETURN. 4. PRODUCT.# 03.333.301, LOT # UNKNOWN, QUANTITY 2. THESE TWO ITEMS ARE POWER SHAFTS T6 AND THE TIPS OF THEM WERE STRIPPED. THESE ITEMS ARE NOT AVAILABLE FOR RETURN DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709612 ↗
• MalfunctionJul 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HANDLES ARE LEAVING A BROWN STAIN IN POUCHES AFTER STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460918 ↗
• MalfunctionJan 31, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER HEADS ARE STRIPPED. THEY DO NOT ENGAGE SCREW HEADS PROPERLY ANYMORE. THE REPLACEMENT SCREWDRIVER WAS USED TO PROCEED WITH THE PROCEDURE. THERE WAS A TWO MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285329 ↗
• MalfunctionMar 25, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON MARCH 7, 2024, THAT THE SCREWDRIVER HANDLE IS CHIPPING AWAY WITH STERILIZATION. THERE WERE NO PATIENT OUTCOME AND CONSEQUENCES. THIS REPORT IS FOR ONE (1) SCRDRIVER T25 SELF-HOLDING L290 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967664 ↗
• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE METAL SHAFT OF THE SCREWDRIVER IN QUESTION HAD BROKEN LOOSE FROM THE WOODEN HANDLE. WHEN TIGHTENING A SCREW, THE HANDLE BROKE LOOSE AND WAS UNABLE TO COMPLETE TIGHTENING OF THE SCREW. THE ISSUE WAS FOUND DURING A QUALITY CHECK AFTER THE SET ARRIVED BACK FROM A CASE. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER T25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395850 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING INTRA-OP PATIENT REQUESTED TO HAVE BIL EX TIBIA NAILS, AND SCREWS, REMOVED DUE TO PAIN AND IRRITATION. THE IMPLANTS ON THE RIGHT SIDE WERE REMOVED WITHOUT INCIDENT. THE IMPLANTS ON THE LEFT WERE DIFFICULT. THE END CAP WAS REMOVED, AND NAIL EXTRACTOR THREADED INTO NAIL. THE DISTAL SCREW WAS REMOVED. WHILE ATTEMPTING TO REMOVE PROXIMAL SCREW, THE SCREW HEAD BROKE OFF OF THE SHAFT, AND LOOKED TO BE COLD WELDED INTO THE HEAD OF THE SCREW. THE BROKEN SCREW REMOVAL SET WAS OPENED AND SURGEON ATTEMPTED TO GET SCREW SHAFT OUT OF NAIL/TIBIA. THE BROKEN SCREW REMOVAL INSTRUMENTS WERE UNABLE TO ASSIST IN REMOVING THE SCREW SHAFT. THE SURGEON HAD TO OPEN SKIN MEDIALLY, AND USE AN OSTEOTOME TO CUT BONE AWAY FROM SCREW ON LATERAL AND MEDIAL SIDES. HE WAS THEN ABLE TO TAMP THE SCREW SHAFT OUT OF PATIENT. HE THEN PROCEEDED TO REMOVE THE NAIL. THERE WAS SURGICAL DELAY OF SIXTY (60) MINUTES. ACTION WAS TAKEN OF OPENED ADDITIONAL SETS/INSTRUMENTS, X-RAY WERE TAKEN AND THERE WERE FRAGMENTS GENERATED AND THE FRAGMENTS WERE REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCES ARE UNKNOWN. THIS COMPLAINT IN

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 16247327 ↗
• MalfunctionSep 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SCREWDRIVER WAS NOT SEATING WELL INTO SCREW HEADS. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SDDRIVE SCREWDRIVER T25 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15450973 ↗
• MalfunctionJul 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREWDRIVER WOULD NOT FIT PROPERLY INTO 5.0MM SCREW WITH T25 RECESS. ANOTHER T25 SCREWDRIVER WAS OPENED AND SCREWS WERE INSERTED WITHOUT DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK SCREWS-TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) SDDRIVE SCREWDRIVER T25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080409 ↗
• MalfunctionJan 31, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE SDDRIVE SCREWDRIVER WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SCRDRIVER T25 SELF-HOLDING L290 THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392508 ↗
• MalfunctionJan 10, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON DECEMBER 13, 2021, FOUR (4) SCREWDRIVERS WERE STAINING THE PLASTIC STERILE PEEL POUCHES. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SDDRIVE(TM) SCREWDRIVER T25. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204300 ↗
• MalfunctionJun 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING FIELD INSPECTION AND STERILE PROCESSING, ALL THE SIMILI WOOD HANDLE OF THE SCREWDRIVER ARE LEAVING RESIDUE IN THE PEEL PACK. A BROWN SPOT MAKING THE RESPONSIBLE THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T25. THIS REPORT IS 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084058 ↗
• MalfunctionApr 5, 2021Break; Break

  VETERINARY COMPLAINT: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A HARDWARE REMOVAL ON A DEAD HORSE, THE STARDRIVE SCREWDRIVER T5 BROKE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SD DRIVE SCREWDRIVER T25. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613904 ↗
• MalfunctionNov 11, 2020Break; Break

  IT WAS REPORTED THAT WHILE INSPECTING BACK UP ITEMS ON AN UNKNOWN DATE, SOME WERE SET ASIDE FOR COMPLAINTS. ONE (1) STARDRIVE SCREWDRIVER TEETH ARE CHIPPED. TWO (2) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HAD WIRES LOOSE. ONE (1) STARDRIVE SHAFT TEETH WAS CHIPPED. AND ONE (1) INTERLOCKING SCREWDRIVER IS WARPED AND SHIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER T25. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10825186 ↗
• MalfunctionOct 8, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, THE FINISH ON HANDLE WAS COMING OFF AND MAKING THE HANDLE NOT SAFE TO STERILIZE. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER T25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10652184 ↗
• MalfunctionJan 17, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) SYNTHES MULTI LOC GRAPHIC CASES WERE NOTICED TO HAVE PEELED OFF. THE REPORTED GRAPHIC CASES WERE NOT USED IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE STARDRIVE SCREWDRIVER T25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9603125 ↗
• MalfunctionNov 15, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INSPECTION, A STARDRIVE SCREWDRIVER WAS NOTICED TO BE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9328446 ↗
• MalfunctionApr 25, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, CUSTOMER REPORTED DISSATISFACTION WITH THE PHENOLIC HANDLES OF THE FOLLOWING DEVICES: ONE (1) STARDRIVE SCREWDRIVER T25, ONE (1) SCREWDRIVER HEXAGONAL WITH HOLDING SLEEVE, ONE (1) SCREWDRIVER STARDRIVE, ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER. THE CUSTOMER HAS A MANDATE TO ELIMINATE ALL "WOODEN STYLE" HANDLES FROM THEIR FACILITIES WHEREVER POSSIBLE. UPON INITIAL INSPECTION OF THE RETURNED DEVICES, THESE DEVICES WERE NOTED TO HAVE DEFECTS. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T25. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8551196 ↗
• MalfunctionOct 3, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE T25 STARDRIVE SCREWDRIVER WAS NOTICED TO BE LOOSE AND THE SHAFT PORTION DISCONNECTED OR BROKE OFF FROM THE HANDLE. THE ISSUE WAS IDENTIFIED AT THE BACK TABLE WHEN THE SURGICAL TECHNICIAN WAS PREPARING FOR THE CASE WHILE THE OPERATING ROOM (OR) TEAM WAS POSITIONING THE PATIENT. THE PROCEDURE WAS A SIMPLE IMPLANT REMOVAL OF A COUPLE SCREWS. THE PROCEDURE WAS COMPLETED UNEVENTFULLY WITHOUT ANY DELAY. THE ISSUE DID NOT IMPACT THE PROCEDURE OR THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929703 ↗
• MalfunctionSep 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, THAT THE HANDLE OF THE FOLLOWING SCREWDRIVERS; (2) BALL HEX SCREWDRIVER, (2) FLEXIBLE HEXAGONAL SCREWDRIVER, SCREWDRIVER T25 L380, STARDRIVE SCREWDRIVER T25, HAMMER (2) AND SLIDE HAMMER FOR HAMMER GUIDE (2) LEAVES AN OILY DEPOSIT IN THE BOTTOM OF THE BOXES. THE STERILIZATION EQUINE HAD THE SCREWDRIVERS CLEANED ALONE AND PACK THEM INTO INDIVIDUAL BAGS. THE OILY STAINS ARE REAPPEARED IN A FEW HOURS. NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS 10 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7879032 ↗
• MalfunctionFeb 23, 2018Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF ONE (1) STARDRIVE SCREWDRIVER WAS STRIPPED AND WAS NO LONGER FUNCTIONAL. THIS WAS IDENTIFIED BY THE MEDICAL DEVICE REPROCESSING (MDR, LIKE STERILE PROCESSING DEPARTMENT) STAFF DURING THE CLEANING PROCESS. THE MDR STAFF NOTED THAT THE SCREWDRIVER WAS BADLY STRIPPED AND UPON TESTING WITH UNKNOWN QUANTITY OF UNKNOWN SCREWS, IT DID NOT WORK AS INTENDED. IT IS UNKNOWN WHEN THE MALFUNCTION OCCURRED, HOWEVER, AT THE TIME OF DISCOVERING THE FAULT, THERE WAS NO PATIENT OR PROCEDURAL INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7293756 ↗
• MalfunctionDec 14, 2017Break; Break

  FURTHER IT WAS CLARIFIED THAT THE PATIENT HAD A FRACTURE WHICH WAS SLIGHTLY DISTAL TO THE SYNTHES LISS FEMUR PLATE AND THE PLAN WAS TO REVISE THE PATIENT TO ANOTHER ZIMMER PLATE. HENCE THE REVISION SURGERY WAS CONDUCTED. HE ALSO SAID THAT ALL PARTS THAT WERE IMPLANTED EARLIER WERE INTACT WHEN THE SURGERY BEGAN AND THE SCREWS THAT WERE COLD WELDED WERE THE ONLY ONES THAT BROKE / GOT DAMAGED TO REMOVE THEM DURING THE SURGERY. THIS REPORT ADDRESSES INTRAOPERATIVE ISSUE OF THREE (3) BROKEN SCREWDRIVERS AND THREE COLD WELDED / CROSS THREADED SCREWS THAT WERE STUCK TO THE PLATE. THE POSTOPERATIVE REVISION DUE TO PATIENT¿S FRACTURE WHICH WAS SLIGHTLY DISTAL TO THE SYNTHES LISS FEMUR PLATE HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 10), LISS PLATE (PART # 422.348, LOT # 2142869, QUANTITY # 1). THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7117431 ↗