NA 313.93Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982188243), received between May 22, 2017 and Jul 1, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Crack; Crack

  IT WAS REPORTED THAT THE HANDLE HAD A CRACK ON IT AFTER AN ORTHOPEDIC PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374800 ↗
• MalfunctionMay 13, 2025Corroded; Corroded

  IT WAS REPORTED THAT THERE WAS PITTING ON DEVICE. NO OPERATION WAS INVOLVED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012503 ↗
• MalfunctionSep 18, 2024Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, AFTER THE INSTRUMENTS HAD GONE THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT THERE WERE SEVERAL INSTRUMENTS THAT WERE DAMAGED AND WERE NOT ABLE TO BE USED ANYMORE. 1. REPLACEMENT SCREW FOR INSERTION GUIDE THIS ITEM WAS A CONNECTION SCREW FOR THE PROXIMAL HUMERUS DRILL GUIDE ATTACHMENT. THE SCREW WAS LOST AND UNABLE TO BE FOUND. 2. RAD AIMING ARM/FRN PIRIFORMIS FOSSA THIS WAS AN AIMING ARM ATTACHMENT FOR THE FRNA. ONE OF THE PLASTIC FLAPS THAT LOCKS THE DRILL SLEEVE IN PLACE WAS BROKEN. 3. CANNULATED 4.0MM HEXAGONAL SCREWDRIVER THIS ITEM WAS A CALCULATED SCREWDRIVER AND THE TIP OF THE SCREWDRIVER WAS STRIPPED. 4. 4.0MM HEXAGONAL SCREWDRIVER THIS ITEM WAS A SOLID 4 MM HEX SCREWDRIVER. THIS SCREWDRIVER HAD RUST AND WHERE ON THE HANDLE. 5. 2.7/3.5MM DEPTH GAUGE 0 TO 60MM THIS ITEM WAS A DEPTH GAUGE AND THE TIP OF THIS DEATH GAUGE BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT WITH THESE ITEMS. IT WAS UNKNOWN HOW THEY WERE DAMAGED OR WHEN THEY WERE DAMAGED. THIS REPORT IS FOR A 4.0MM HEXAGONAL SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246041 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123080 ↗
• MalfunctionApr 20, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE WOOD HANDLED INSTRUMENTS ARE LEAVING A STAIN/RESIDUE WHEN THEY ARE PEEL-PACKED AND STERILIZED. THERE WERE NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR ONE (1) 4.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 9 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781360 ↗
• 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 (B)(6) 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) 4.0MM HEXAGONAL SCREWDRIVER THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204340 ↗
• MalfunctionDec 22, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE HANDLE OF 4.0MM HEXAGONAL SCREWDRIVER IS SPLITTING. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13064756 ↗
• MalfunctionJun 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES EUROPE 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) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER. THIS REPORT IS 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084053 ↗
• MalfunctionMay 13, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE HANDLE OF THE SCREWDRIVER LEFT A RESIDUE IN THE PEELPAK WHEN STERILIZED. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820051 ↗
• MalfunctionOct 27, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF A 4MM HEXAGONAL SCREWDRIVER IS WORN AND IS HAVING TROUBLE GRIPPING ONTO THE SCREWS. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10742745 ↗
• MalfunctionAug 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS FOR ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10396379 ↗
• MalfunctionJun 14, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT A 4.00MM HEXAGONAL SCREWDRIVER AND A (2) CANNULATED 4.00MM HEXAGONAL SCREWDRIVER HANDLES ARE LEAKING DYE INSIDE THE INSTRUMENT TRAY OF THE LOCKING PERIARTICULAR PLATING SET. THERE IS NO PATIENT INVOLVEMENT. THIS IS COMPLAINT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8699776 ↗
• MalfunctionMar 5, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INSPECTION, THE HEXAGONAL SCREWDRIVER WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8390341 ↗
• MalfunctionMay 23, 2018Dent in Material; Dent in Material

  (B)(6) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT THE MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED A SMALL DENT IN THE HEXAGONAL TIP OF A SCREWDRIVER HEAD AND ANOTHER HEXAGONAL SCREWDRIVER HAD A CRACKED HEAD TIP. BOTH ITEMS WERE NO LONGER FUNCTIONAL AFTER TESTING WITH CORRESPONDING SCREW HEAD RECESS. THE TWO COMPLAINED ITEMS WERE DISCARDED. THIS EVENT DID NOT TAKE PLACE DURING SURGERY AND THERE IS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 4.0MM HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7537752 ↗
• MalfunctionFeb 23, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT PATIENT HAD REVISION SURGERY ON (B)(6) 2017 FOR SCAR REVISION AND HARDWARE REMOVAL DUE TO PAINFUL HARDWARE. UNKNOWN WHICH HARDWARE WAS PAINFUL. THE SURGEON HAD DIFFICULTY REMOVING THE SCREWS WITH BOTH SCREWDRIVERS. THE SCREWDRIVERS WERE NOTED TO HAVE ROUNDED TIPS. ANOTHER SET OF SCREWDRIVERS WERE USED TO SUCCESSFULLY REMOVE THE SCREWS. THERE WERE NO ISSUES WITH THE HARDWARE. PATIENT HAD HEALED AND REQUESTED THAT THE PAINFUL HARDWARE BE REMOVED. DURING THE SCAR REVISION, THE SURGEON DISSECTED AN INCH-WIDE SCAR ON THE LATERAL KNEE AND SUTURED IT BACK TOGETHER TO REDUCE THE SIZE OF THE SCAR. THERE WAS NO SURGICAL DELAY. ROUTINE X-RAYS WERE TAKEN AS STANDARD FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. DURING MANUFACTURER INVESTIGATION PROCESS OF THE RETURNED HEXAGONAL SCREWDRIVER, IT WAS IDENTIFIED THE HEX POINT/EDGES ARE WORN/ROUNDED/STRIPPED. THIS CONDITION WAS REEVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS REPORT ADDRESSES THE SCREWDRIVERS WITH ROUNDED TIPS. DIFFICULTY REMOVING SCREWS. REMOVAL OF THE PAINFUL HARDWARE (PLATE AND SCREWS) HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: 5.0MM CANNULAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7293381 ↗
• MalfunctionFeb 23, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT PATIENT HAD REVISION SURGERY ON (B)(6) 2017 FOR SCAR REVISION AND HARDWARE REMOVAL DUE TO PAINFUL HARDWARE. UNKNOWN WHICH HARDWARE WAS PAINFUL. THE SURGEON HAD DIFFICULTY REMOVING THE SCREWS WITH BOTH SCREWDRIVERS. THE SCREWDRIVERS WERE NOTED TO HAVE ROUNDED TIPS. ANOTHER SET OF SCREWDRIVERS WERE USED TO SUCCESSFULLY REMOVE THE SCREWS. THERE WERE NO ISSUES WITH THE HARDWARE. PATIENT HAD HEALED AND REQUESTED THAT THE PAINFUL HARDWARE BE REMOVED. DURING THE SCAR REVISION, THE SURGEON DISSECTED AN INCH-WIDE SCAR ON THE LATERAL KNEE AND SUTURED IT BACK TOGETHER TO REDUCE THE SIZE OF THE SCAR. THERE WAS NO SURGICAL DELAY. ROUTINE X-RAYS WERE TAKEN AS STANDARD FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. DURING MANUFACTURER INVESTIGATION PROCESS OF THE RETURNED HEXAGONAL SCREWDRIVER, IT WAS IDENTIFIED THE HEX POINT/EDGES ARE WORN/ROUNDED/STRIPPED. THIS CONDITION WAS REEVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS REPORT ADDRESSES THE SCREWDRIVERS WITH ROUNDED TIPS. DIFFICULTY REMOVING SCREWS. REMOVAL OF THE PAINFUL HARDWARE (PLATE AND SCREWS) HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: 5.0MM CANNULAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7293380 ↗
• MalfunctionMay 22, 2017Bent; Bent

  IT WAS REPORTED THAT TWO INSTRUMENTS WERE DISCOVERED DAMAGED IN STERILE PROCESSING. THE TIP IS BROKEN OFF ON ONE SIDE OF THE SCREW FORCEPS AND THE TIP IS BENT ON THE 4MM HEX SCREWDRIVER. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6583219 ↗