NA 313.96.96Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982188274), received between Aug 30, 2017 and Oct 15, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SCREWDRIVER HANDLE WAS CRACKED/BROKEN. NO PATIENT WAS INVOLVED. NO OPERATION WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451168 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT FIELD SERVICE LOCATION, IT WAS OBSERVED THAT THE CRUCIFORM SCREWDRIVER WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399195 ↗
• MalfunctionJan 22, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE CRUCIFORM SCREWDRIVER WOOD HANDLE BROKE DURING THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE 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 9616331 ↗
• MalfunctionAug 16, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING OPEN REDUCTION INTERNAL FIXATION OF A HAND FRACTURE ON AN UNKNOWN DATE, ONE (1) HOLDING SLEEVE FOR SCREWS AND ONE (1) CRUCIFORM SCREWDRIVER HAD AN UNKNOWN MALFUNCTION. ANOTHER DEVICE SET WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME WAS NORMAL. UPON MANUFACTURER RECEIPT AND INVESTIGATION, IT WAS DETERMINED THAT THE TIP OF THE CRUCIFORM SCREWDRIVER WAS STRIPPED. THIS REPORT IS FOR A CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8901131 ↗
• MalfunctionDec 5, 2017Break; Break

  IT WAS REPORTED THAT THE TIP IS BROKEN OFF ON A CRUCIFORM SCREWDRIVER. THIS WAS DISCOVERED IN STERILE PROCESSING. NO KNOWN PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7083395 ↗
• MalfunctionAug 30, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SCREW DRIVER WOODEN HANDLES FROM A MODULAR HAND SYSTEM ARE BLEEDING AND LEAVING STAINS ON THE LIDS AND CAUSING A CONCERN. THERE IS NO PATIENT INVOLVED AS THIS IS HAPPENING IN STERILE PROCESSING DEPARTMENT. THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6832092 ↗