NA 314.48.96Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982188946), received between Sep 28, 2018 and Dec 14, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE USING THE CRUCIFORM DRIER FOR 1.0 SCREWS OUT OF THE MODULAR HAND, THE RETAINING SLEEVE KEPT GETTING STUCK AT THE BASE OF THE DRIVER. ANOTHER MODULAR HAND SET WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.0MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977385 ↗
• MalfunctionJun 18, 2021Break; Break

  IIT WAS REPORTED THAT, THE 1.3 CRUC SCRDRIVER BLADE HOLDING SLEEVE AND SCRDRIVERSHAFT-CRUCIF 1 W/HOLD-SLEEVE GR WERE FOUND BROKEN. NO PATIENT CONSEQUENCES NOTED. THIS REPORT IS FOR ONE (1) 1.0MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028577 ↗
• MalfunctionDec 18, 2020Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION AT THE WAREHOUSE ON AN UNKNOWN DATE, THE CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE TIP IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES 1 1.0MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11036938 ↗
• MalfunctionFeb 27, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE ROUTINE INCOMING INSPECTION, THE CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS OBSERVED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE 1.0MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9762724 ↗
• MalfunctionSep 19, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING ROUTINE CHECK, ALL OF THE SCREWDRIVER SHAFTS IN MODULAR HAND SET WERE STRIPPED AND UNABLE TO PLACE SCREWS. IF ATTEMPTED TO USE IN SURGERY, THESE SHAFTS WOULD BE USELESS. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 FOR 2 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9087752 ↗
• MalfunctionMar 19, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, DURING STERILE PROCESSING, THE INSERT OF THE CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE WOULD NOT GO IN PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A CRUCIFORM SCREWDRIVER BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8432649 ↗
• MalfunctionNov 7, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE SCREWDRIVER HANDLE WOULD NOT ATTACH TO THE SCREWDRIVER SHAFT. THE DEVICE THAT ENGAGES TO THE SELF-RETAINING SCREW WOULD NOT RETAIN IN THE SCREW WHEN TRIED TO PULL IT OUT ON THE IMPLANT SET. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF THIRTY (30) MINUTES. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 1.0MM CRUCIFORM SCREWDRIVER BLADE WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 8047920 ↗
• MalfunctionSep 28, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN HAND SURGERY ON (B)(6) 2018. THE SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS FOUND TO HAVE AN ISSUE. IT WAS ALSO NOTICED THAT THE 2 HANDLES WITH MINI QUICK COUPLING WERE STUCK TOGETHER WITH THE CRUCIFORM SCREWDRIVER BLADES. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY AND IF SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920296 ↗
• MalfunctionSep 28, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN HAND SURGERY ON (B)(6) 2018. THE SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS FOUND TO HAVE AN ISSUE. IT WAS ALSO NOTICED THAT THE 2 HANDLES WITH MINI QUICK COUPLING WERE STUCK TOGETHER WITH THE CRUCIFORM SCREWDRIVER BLADES. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY AND IF SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920276 ↗