NA 313.96Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10887587037189), received between Jan 23, 2017 and Aug 4, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (11 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.

• MalfunctionAug 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132323 ↗
• MalfunctionOct 22, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SCREWDRIVER HANDLES ARE LEAVING BROWN MARKS IN POUCHES AFTER STERILIZATION. THE HANDLES ARE CREATING DEBRIS. THE EVENT OCCURRED DURING FIELD INSPECTION AND STERILE PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507339 ↗
• MalfunctionApr 3, 2023Material Twisted/Bent; Material Twisted/Bent

  THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663273 ↗
• MalfunctionApr 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TIP OF SCREWDRIVER DOES NOT ENGAGE SCREW HEADS PROPERLY. PLEASE REPLACE AT NO CHARGE DIRECTLY TO THE CUSTOMER ON PO# (B)(4). CONCOMITANT DEVICE REPORTED: UNK: SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE(1) DEVICE CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210814 ↗
• MalfunctionDec 2, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE THE SCREWDRIVER STRIPPED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12918753 ↗
• MalfunctionMay 10, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, CRUCIFORM SCREWDRIVER THAT HAS A BROKEN TIP AND THE DRIVER BIT HAS CRACK. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11796917 ↗
• MalfunctionSep 4, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION OF SETS, ONE (1) BOLT CUTTER CUTTING EDGE WAS CHIPPED, TWO (2) DEPTH GAUGE OUTER SLEEVE FALLS OFF DUE TO MISSING BEARING, ONE (1) DEPTH GAUGE HAS A BROKEN TIP, ONE (1) GUIDE SLEEVE HAS A BROKEN/BENT TIP, ONE (1) CANNULATED STARDRIVE TWISTED TIP, TWO (2) SCREWDRIVERS HAS A BROKEN TIP. ONE (1) DRIVING CAP HAS A BROKEN TIP, ONE (1) EXTRACTION INSTRUMENT WAS STRIPPED INSERTION THREADS, ONE (1) HANDLE WITH QUICK COUPLING HAS A BROKEN HANDLE, ONE (1) HANDLE SLEEVE WITH UNKNOWN ALLEGATION: ONE (1) TORQUE LIMITER AND ONE (1) TENSION HOLDER DRIVER WON'T LOCK, AND ONE (1) DRILL SLEEVE HAS AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FIFTEEN (15) DEVICES. THIS REPORT IS FOR (1) CRUCIFORM SCREWDRIVER THIS IS REPORT 5 OF 8 (B)(4) RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497214 ↗
• MalfunctionJun 22, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE 2.4MM CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE WAS DAMAGED WITH A BROKEN HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10182590 ↗
• MalfunctionJan 29, 2020Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REDUCTION FORCEPS WITH POINTS RACHET AND SYNFIX® EVOLUTION AIMING WERE NOT FUNCTIONING. A DEPTH GAUGE FOR MINI SCREWS WAS OBSOLETE AND ANOTHER DEPTH GAUGE WAS ALSO BROKEN DURING REVERSE LOGISTICS INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644151 ↗
• MalfunctionOct 25, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE THE SURGEON WAS PERFORMING A 2.4 TIBIAL-PLATEAU-LEVELING OSTEOTOMY (TPLO) AND TIGHTENING A CORTEX SCREW, THE TIP OF THE CRUCIFORM SCREWDRIVER SHEARED OFF THE DRIVER. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY REPORTED WITH AN UNKNOWN NUMBER OF MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN UNKNOWN PERIOSTEAL ELEVATOR. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE: UNKNOWN CORTEX SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN TPLO PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9238274 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION ON AN UNKNOWN DATE, THAT THE TIP OF A CRUCIFORM SCREWDRIVER WAS NOTED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9077845 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A CRUCIFORM SCREWDRIVER HANDLE WAS FOUND BROKEN DURING A ROUTINE INSPECTION. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9071054 ↗
• MalfunctionMay 16, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING STERILE PROCESSING, THE CRUCIFORM SCREWDRIVER HANDLE BROKE. THERE WAS NO PATIENT INVOLVEMENT.  THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8616551 ↗
• MalfunctionMay 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2019, DURING ROUTINE INCOMING INSPECTION, A CRUCIFORM SCREWDRIVER WAS DISCOVERED AS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8591766 ↗
• MalfunctionDec 7, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE TIP OF THE CRUCIFORM SCREW DRIVER FOR THE 2.0MM AND 2.4MM SCREWS IN THE MODULAR FOOT, BROKE DURING AN UNKNOWN PROCEDURE. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE BUT THEY WERE EASILY REMOVED. THERE WAS NO SURGICAL DELAY DUE TO RECONNECTING REAMER IRRIGATOR ASPIRATOR (RIA) TUBE ASSEMBLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8143693 ↗
• MalfunctionAug 15, 2018Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2018, THE CENTRAL PROCESSING MANAGER PRESENTED ONE (1) PERIOSTEAL ELEVATOR CURVED BLADE-ROUND EDGE, ONE (1) PERIOSTEAL ELEVATOR CURVED BLADE-STRAIGHT EDGE, ONE (1) CRUCIFORM SCREWDRIVER, AND ONE (1) REDUCTION FORCEPS WITH POINTS RATCHET THAT WERE CRACKED OR BROKEN. IT WAS UNKNOWN WHEN THE DEVICES BECAME DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7784459 ↗
• MalfunctionJan 23, 2017Break; Break

  DURING A REVISION SURGERY ON (B)(6) 2016, TO REMOVE A GENERATION DORSAL DISTAL RADIUS PLATE (PI PLATE) AND SCREWS, THE SURGEON COULD NOT REMOVE THE PLATE UNTIL HE BURRED OFF THE HEADS OF ALL SCREWS. THREE SCREW HEADS REMAIN IMPLANTED AND ALL SCREW SHAFTS REMAIN IMPLANTED BECAUSE THE SURGEON COULD NOT REMOVE THEM. IN AN ATTEMPT TO REMOVE THE SCREWS, TWO BURR ROUND DEVICES, ONE BURR EGG, AND A SCREWDRIVER WERE STRIPPED. HE WAS ABLE TO BEND AND LOOSEN THE PLATE AND EXPLANT MOST OF IT BECAUSE THE PLATE EVENTUALLY BROKE. SURGERY WAS DELAYED APPROXIMATELY 90 MINUTES. ONE PIECE OF THE PLATE REMAINED IN THE RADIUS. IT WAS STATED THAT THE SURGERY PROCEEDED AS NORMAL AFTER THE DELAY IN HARDWARE REMOVAL. PATIENT IS IN A STABLE CONDITION. CONCOMITANT MEDICAL PRODUCTS: HOLDING SLEEVE (PART# 313.97, LOT# 3057596, QUANTITY 1); AIR PEN DRIVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT NUMBER 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6269477 ↗