NA 314.070Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886982188458), received between Jan 13, 2016 and Mar 5, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Device Slipped; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS AN INTRAOPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523788 ↗
• MalfunctionDec 10, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN USING THE 2.5 SCREWDRIVER IT WAS NOTICED THAT THE DRIVER WASN¿T ENGAGING WITH THE HEAD OF THE C CLAMP. UPON INSPECTION IT WAS IDENTIFIED THAT THE HEAD OF THE DRIVER IS BROKEN. THE SURGICAL TEAM PROCEEDED WITHOUT THE C CLAMP, RESULTING IN A MINIMAL DELAY TO THE SURGERY. THERE WERE NO KNOWN ADVERSE CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772682 ↗
• MalfunctionJul 24, 2025Break; Break

  THE DOCTOR WAS USING THE SCREWDRIVER TO REMOVE A 3.5 SCREW AND THE WOODEN HANDLE BROKE WITHOUT MUCH EFFORT WHEN STARTING USE. ADDITIONALLY, IT WAS FOUND IN THE OPERATING ROOM THAT A MISSING SCREW OF 5.0 L 70 MM WAS STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592390 ↗
• MalfunctionFeb 7, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT? -YES, JUST A FEW MINUTES TO RINSE THE WOUND THOROUGHLY TO EVACUATE ANY SMALL DEBRIS THAT MAY FALL. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -NO C. WERE THERE PIECES BROKEN OFF FROM THE INSTRUMENT? IF YES, DID IT BREAK INTO 2 OR MORE PIECES? -YES, THE INSTRUMENT BROKE INTO MORE THAN 2 PIECES D. WERE THE BROKEN FRAGMENTS RETAINED IN THE PATIENT? (YES OR NO): -NO VISIBLE FRAGMENTS REMAINED IN THE PATIENT E. WAS OTHER MEDICAL INTERVENTION REQUIRED? IF YES, PLEASE SPECIFY DETAILS. -NO 7. WAS THE SURGERY COMPLETED SUCCESSFULLY? (YES OR NO): -YES.

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

  MAUDE report 21335064 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER BROKE OFF INTRAOPERATIVELY DURING METAL REMOVAL SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20868196 ↗
• MalfunctionDec 1, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT A SCREWDRIVER BROKE DURING SURGERY ON (B)(6) 2023. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18251034 ↗
• MalfunctionDec 1, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING REPROCESSING/STERILIZATION ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE KEY WAS WORN. THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18246399 ↗
• MalfunctionJul 20, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. BEFORE SURGERY, WHEN THE PRODUCTS WERE PREPARED AND CHECKED AFTER STERILIZATION, THE ADHESION OF VISCOUS LIQUID ON THE SURFACE OF THE HANDLE WAS CONFIRMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17366563 ↗
• MalfunctionAug 30, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER WAS WORN. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319670 ↗
• MalfunctionApr 21, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT 314.070; 3.5 HEXAGONAL SCREWDRIVER WAS SPLIT, BROKEN. THERE WAS NO PATIENT CONSEQUENCES. NO MORE INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) SCREWDRIVER-HEX ÿ2.5 W/GROOVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14175460 ↗
• MalfunctionApr 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PEDIATRIC PATIENT UNDERWENT THE CORRECTIVE OSTEOTOMY FOR THE FEMUR. WHEN THE SURGEON WAS INSERTING THE LOCKING SCREW, THERE SEEMED TO BE A SENSE OF POOR MATING BETWEEN THE SCREWDRIVER AND THE LOCKING SCREW IN THE SURGERY COMPARED TO OTHER LOCKING SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047847 ↗
• MalfunctionApr 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PEDIATRIC PATIENT UNDERWENT THE CORRECTIVE OSTEOTOMY FOR THE FEMUR. WHEN THE SURGEON WAS INSERTING THE LOCKING SCREW, THERE SEEMED TO BE A SENSE OF POOR MATING BETWEEN THE SCREWDRIVER AND THE LOCKING SCREW IN THE SURGERY COMPARED TO OTHER LOCKING SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047842 ↗
• MalfunctionJan 4, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SCREWDRIVER BROKE. IT IS UNKNOWN WHEN AND HOW THE ISSUES OCCURRED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154744 ↗
• MalfunctionMay 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE NON-ACCEPTANCE OF THE INSTRUMENT WITH CABLE IN CELERON MATERIAL BY (B)(6), WE CONSULTED WITH NURSE (B)(6), RESPONSIBLE FOR THE TECHNICAL AREA OF THE HOSPITAL'S MATERIALS CENTER. IT IS A MATERIAL THAT HAS POROSITY DUE TO EXPOSURE TO THE TEMPERATURE OF THE STERILIZATION PROCESS. IT IS THE POROSITY OF THE CELERON THAT COMPROMISES THE CLEANING PROCESS. IT WAS UNDERSTOOD THEN THAT THE MATERIAL COMPROMISES THE STERILIZATION PROCESS, SINCE IT HAS POROSITY THAT DOES NOT GUARANTEE THE EFFECTIVENESS OF CLEANING. IF YOU ARE NOT IN ACCORDANCE WITH THE JUSTIFICATION PRESENTED, I SUGGEST THAT YOU PRESENT TO THE HOSPITAL TECHNICIANS RESPONSIBLE, A DOCUMENT WITH THE MANUFACTURER'S SPECIFICATIONS THAT MEET THE STANDARDS OF THE MANUALS OF GOOD CLEANING AND STERILIZATION PRACTICES. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS. THIS IS REPORT 5 OF 15 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863578 ↗
• MalfunctionMar 9, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THAT THE INSTRUMENT WAS DELIVERED BROKEN. THE TIP OF THE DRIVER WAS MISSING. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SCREWDRIVER-HEX ¿¿2.5 W/GROOVE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448690 ↗
• MalfunctionMar 23, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF SCREWDRIVER WAS USED AND BECAME DAMAGED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865281 ↗
• MalfunctionDec 11, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AFTER STERILE PROCESSING THE SCREWDRIVER WAS FOUND IN BROKEN CONDITION IN STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. CUSTOMER WANTS TO KNOW WHAT IS THE MATERIAL USED IN THIS SCREWDRIVER. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9453009 ↗
• MalfunctionOct 11, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HANDLE OF THE HEXAGONAL SCREWDRIVER WAS FOUND BROKEN AFTER AUTOCLAVE IN STERILIZATION DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9179551 ↗
• MalfunctionAug 7, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE A SMALL HEX SCREWDRIVER FROM THE USS DUAL SET WAS STRIPPED AND WAS MALFUNCTIONING DUE TO WEAR AND TEAR. NO PATIENT WAS AFFECTED BY THESE MALFUNCTIONS. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER 2.5 MM WIDTH ACROSS FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870058 ↗
• MalfunctionJun 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2019, THE TIP OF SCREWDRIVER HEXAGONAL WITH GROOVE WAS SPINNING INSIDE THE SCREW HEAD. A REPLACEMENT SCREWDRIVER WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF TWO (2) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A SMALL HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 8734609 ↗
• MalfunctionMay 29, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OSTEOSYNTHESIS SURGERY WITH THE PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM (PHILOS) DUE TO A FRACTURE. DURING THE IMPLANTATION OF THE PROXIMAL HUMERAL PLATE, IT WAS IMPOSSIBLE TO REMOVE THE PLATE FROM THE INSERTION HANDLE. THE SURGEON REMOVED THE IMPLANTED PLATE DUE TO IT WAS IMPOSSIBLE TO DETACH THE INSERTION HANDLE AND ANOTHER PLATE WAS IMPLANTED BUT NOT MINI-INVASIVE. THERE WAS A SURGICAL DELAY OF AT LEAST 2 HOURS. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. DUE TO SYSTEM LIMITATION, THIS EVENT IS CAPTURED UNDER THIS (B)(4) AND LINKED (B)(4). CONCOMITANT DEVICE: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN) . THIS REPORT IS FOR ONE (1) SCREWDRIVER. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650089 ↗
• MalfunctionApr 11, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE ONE (1) 2.5MM HEXAGONAL SCREWDRIVER WITH GROOVE WAS FOUND TO HAVE SPOTS ON THE PACK AND WERE ONLY NOTICED IN THE OPENING OF THE KIT WHEN THE PATIENT WAS IN THE ANESTHETIZED ROOM. THE SURGEON DID NOT USE J&J MATERIAL AND REQUESTED COMPETITOR MATERIAL. ACCORDING TO THE CUSTOMER, THE USE OF CELERON CABLE INSTRUMENTS WAS NO LONGER ALLOWED BY ANVISA DUE TO THE POSSIBILITY OF IMPREGNATION OF THE DEVICES DURING CLEANING. THE CUSTOMER COMPLAINS THAT AFTER STERILIZATION, THESE INSTRUMENTS HAVE STAINED THE PACKAGING THE USED TO PROTECT THE CABLE DURING STERILIZATION AND REPORTED THAT THE CABLE MATERIALS WAS POROUS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8505472 ↗
• InjuryMar 18, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO REMOVE AN UNKNOWN PLATE AND WAS IMPLANTED WITH ANOTHER PLATE ON THE FEMUR. DURING REMOVAL, A SCREWDRIVER COULD NOT BE ATTACHED TO AN UNKNOWN LOCKING SCREW PROPERLY, THUS, THE SCREW HEAD WAS STRIPPED. THE SCREW WAS REMOVED WITH AN UNKNOWN EXTRACTION TOOL. THE SCREWDRIVER SHAFT WAS NOTED ROUNDED WHEN THE SURGEON CHECKED THE TIP OF THE SHAFT. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PATIENT WAS STABLE AFTER THE SURGERY. CONCOMITANT DEVICE: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8430369 ↗
• MalfunctionSep 25, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A HEXAGONAL SCREWDRIVER WITH GROOVE BROKE WHILE BEING USED IN AN UNKNOWN PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED; IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY OR WHAT THE SURGICAL/PATIENT OUTCOME WERE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7907074 ↗
• MalfunctionAug 21, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT THE ADOLESCENT IDIOPATHIC SCOLIOSIS SURGERY AT TH5. DURING THE SURGERY, THE COUNTER DID NOT FIT THE SCREW HEAD AND THE SURGEON USED THE SCREW HOLDER TO HOLD THE SCREW HEAD TO GUIDE INSERTING THE COUNTER. AFTER FASTENING THE SCREW, IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE WHEN THE SURGEON TRIED TO REMOVE THE DRIVER FROM THE HOLDER. THE BROKEN TIP REMAINED ON THE TOP OF THE SCREW HOLDER AND COULD NOT BE REMOVED. FINALLY, THE SURGEON ATTACHED ANOTHER CHUCK AT THE TOP OF THE HOLDER, SO THAT THE SURGEON COULD REMOVE THE BROKEN FRAGMENT FROM THE HOLDER. THERE WERE NO BROKEN PARTS IN THE PATIENT¿S BODY. SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30 MINUTES SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS COMPLAINT IS FOR A SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS. THE SCREW HOLDER WAS REPORTED IN (B)(4). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7800726 ↗