NA 314.676Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587037646), received between Dec 17, 2019 and May 1, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER THE SURGERY, THE VETERINARIAN CONTACTED THE SALES REPRESENTATIVE, REPORTING THAT THE DEVICE WAS UNABLE TO GRIP THE SCREW PROPERLY, OR WHEN IT DID, THE SCREW WOULD BE POSITIONED AT AN ANGLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057427 ↗
• MalfunctionApr 27, 2026Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THIS SCREWDRIVER IN QUESTION WAS USED TO GRIP THE DEMO SCREW. THE SCREW HOLDER COULD HOLD THE SCREW HEAD, HOWEVER THERE WAS A GAP BETWEEN THE STAR DRIVER AND THE GRIPPED STAR SCREW, WHICH WOULD LEAD THE SCREW TO MOVE LEFT AND RIGHT AFTER GRIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002128 ↗
• MalfunctionFeb 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON JANUARY 11, 2023, THERE IS WEAR OF THE SCREWDRIVER: INITIALLY THE HOLDER WAS LOCKED ON THE SCREWDRIVER AND AFTERWARDS IT DIDN'T STOP TURNING WHEN THEY GOT IT OFF. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) UNK - SCREWDRIVERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284048 ↗
• MalfunctionMay 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN JAPAN THAT ON (B)(6) 2022, A PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY USING THE LCP PLATE FOR FRACTURE OF DISTAL END OF RADIO-ULNA WITH THE DRILL SLEEVE AND THE SCREWDRIVER SHAFT IN QUESTION. ACCORDING TO THE REPORT, THE SURGEON HAD DIFFICULTY IN WEARING THE DRILL SLEEVE WHEN USING THE PLATE, AND IT TOOK TIME IN ALL HOLES. IT WAS FURTHER REPORTED THAT IT WAS DIFFICULT TO INSERT THE SCREW BECAUSE THE SCREW COULD NOT BE ATTACHED VERTICALLY TO THE SCREWDRIVER SHAFT. IT WAS REPORTED THAT BY CHANGING THE SCREWDRIVER SHAFT TO THE SHORT ONE, IT WAS SUCCESSFULLY INSERTED WITHOUT ANY PROBLEM. IT WAS REPORTED THAT DUE TO THESE EVENTS, THE OPERATION SCHEDULED FOR 2 HOURS WAS EXTENDED TO 3 HOURS. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT ANESTHESIOLOGISTS WARNED THE SURGEONS THAT A 3-HOUR OPERATION WAS A HIGH-RISK PROCEDURE FOR PATIENTS IN THEIR 90S. THE SURGEON UNDERSTOOD THAT THE PRODUCT WAS DIFFICULT TO OPERATE DUE TO THE INFLUENCE OF BLOOD ADHESION AND THE THINNESS OF THE PLATE. NO FURTHER I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501444 ↗
• MalfunctionAug 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN, IT WAS CONFIRMED THAT THE SCREWDRIVER SHAFT COULDN¿T HOLD A SCREW PROPERLY. WHEN THE SCREWDRIVER SHAFT HELD THE SCREW, THE SCREW WAS HELD OBLIQUELY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.0MM STARDRIVE SCRWDRVR BLADE W/SPRG HLDG SLV SHRT/66MM MQC. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315558 ↗
• MalfunctionMay 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2021, THE HOLDING SLEEVE FOR THE 2.0 SCREWDRIVER SHAFT HAD A 1.0 SCREW HOLDER (GREEN), THEREFORE IT WAS NOT POSSIBLE TO GRASP THE SCREW WITH IT AND MADE IT DIFFICULT TO INSERT IT INTO THE BONE. PROCEDURE AS COMPLETED SUCCESSFULLY WITH A TWENTY (20) MINUTE DELAY. THIS REPORT IS FOR A 2.0MM STARDRIVE SCREWDRIVER BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11786919 ↗
• MalfunctionFeb 18, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING THE INSPECTION IT WAS NOTICED THAT THE INSTRUMENT DOES PICK THE SCREW UP SKEW. LOCKING SCREWS CAN TILT TO AN ANGLE OF UP TO 10 DEGREES. THERE WERE NO PROCEDURE AND PATIENT INVOLVEMENT ARE REPORTED. UPDATED CONCOMITANT DEVICES REPORTED: UNKNOWN CORTICAL SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.0MM STARDRIVE SCREWDRIVER BLADE W/SPRG HLDG SLV SHRT/66MM MQC. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345539 ↗
• MalfunctionDec 17, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS FURTHER REPORTED THAT SCREWDRIVER DID NOT APPEAR TO BE DAMAGED, IT IS JUST WORN.

  Patient problems: No Patient Involvement

  MAUDE report 9484078 ↗