NA 03.820.101Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034731377), received between Dec 11, 2019 and Dec 18, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (3 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.

• MalfunctionDec 18, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT DURING THE CASE, WHILE USING THE CASPAR DRIVER, A DIFFICULTY IN SECURING THE CASPAR PINS WAS ENCOUNTERED. THEY HAD TO USE BONE WAX TEMPORARILY TO HOLD THE PINS IN PLACE AND PREVENT THEM FROM FALLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844067 ↗
• MalfunctionJun 16, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT DURING THE CASE, WHILE USING THE CASPAR DRIVER, THERE WAS A DIFFICULTY SECURING THE CASPAR PINS. SURGEON HAD TO USE BONE WAX TEMPORARILY TO HOLD THE PINS IN PLACE AND PREVENT THEM FROM FALLING. ADDITIONALLY, ANOTHER DRIVER DID NOT FIT PROPERLY WITH THE LOCKING NUT OF THE RETAINERS. SURGEON HAD TO FORCEFULLY INSERT IT, LIKELY DUE TO A SLIGHT DEFORMATION AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211688 ↗
• MalfunctionNov 18, 2022Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DISTRIBUTOR REPORTED THAT THERE WAS A NON-FUNCTIONING SELF-RETAINING SCREWDRIVER. THE DRIVER WAS NOT HOLDING THE PINS (SCREWS). A SECOND SET WAS USED AND IT RETAINED THE SCREWS, SO IT WAS USED TO COMPLETE THE PROCEDURE ON (B)(6) 2022 SUCCESSFULLY. THE PROBLEM WAS IDENTIFIED PRE-OPERATIVELY; THERE WAS NO DELAY OF THE CASE AND THERE WAS NO CONSEQUENCE TO THE PATIENT. UPON CURSORY EXAMINATION, THE TAB AT THE END OF THE SHAFT THAT SHOULD GRAB THE HEAD OF THE SCREW WAS STRAIGHT AND APPEARED TO BE WHY THE INSTRUMENT WAS NOT FUNCTIONING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SELF-RETAINING SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824438 ↗
• MalfunctionJul 8, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT DURING INSPECTION, THE SELF RETAINING SCREWDRIVER WAS FOUND TO BE WORN. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SELF-RETAINING SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10247684 ↗
• MalfunctionDec 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  FORCEPS WERE USED TO HOLD THE PIN IN PLACE AND THEN THE INSTRUMENT WAS USED TO DRIVE THE PIN IN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9473184 ↗
• MalfunctionDec 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  FORCEPS WERE USED TO HOLD THE PIN IN PLACE AND THEN THE INSTRUMENT WAS USED TO DRIVE THE PIN IN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453937 ↗