NA 313.97Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10887587037196), received between Aug 10, 2018 and Aug 4, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (18 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 25 most recent of 26 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 50132170 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED STATING, "HOLDING SLEEVES DO NOT PICK UP SCREWS. SUSPECT THAT INTERNAL PRONGS ARE BENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604176 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED STATING, "HOLDING SLEEVES DO NOT PICK UP SCREWS. SUSPECT THAT INTERNAL PRONGS ARE BENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604160 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED DURING ROUTINE TESTING ON (B)(6) 2025, THE HOLDING SLEEVES DID NOT FUNCTION PROPERLY. THE HOLDING SLEEVES DID NOT PICK UP SCREWS, AND IT WAS POSSIBLE THAT THE INTERNAL PRONGS WERE BENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604119 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED STATING, "HOLDING SLEEVES DO NOT PICK UP SCREWS. SUSPECT THAT INTERNAL PRONGS ARE BENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604084 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED DURING ROUTINE TESTING ON (B)(6) 2025, THE HOLDING SLEEVES DID NOT FUNCTION PROPERLY. THE HOLDING SLEEVES DID NOT PICK UP SCREWS, AND IT WAS POSSIBLE THAT THE INTERNAL PRONGS WERE BENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604059 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED STATING, "HOLDING SLEEVES DO NOT PICK UP SCREWS. SUSPECT THAT INTERNAL PRONGS ARE BENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604038 ↗
• MalfunctionOct 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SCREWDRIVER BLADE CAN¿T GO THROUGH THE SLEEVE ANYMORE. ANOTHER SCREWDRIVER WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE THIS IS REPORT 1 OF 2 FOR COMPLAINT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961182 ↗
• MalfunctionJul 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE HOLDING SLEEVE WILL NOT HOLD A SCREW. THERE IS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14947048 ↗
• MalfunctionJun 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREW CAPTURE DEVICE WOULD NOT HOLD THE HEAD OF THE IMF SCREW. THERE WAS NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - SCREW: TRAUMA ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES ONE (1) DEVICE HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842084 ↗
• MalfunctionJun 28, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPRINGS WERE BROKEN ON TWO HOLDING SLEEVE DEVICES. THERE WAS NO SURGEON OR PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR PC-(B)(4). THIS REPORT IS FOR A HOLD SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841741 ↗
• MalfunctionMay 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE HOLDING SLEEVE FROM THE IMF SCREW SET WOULD NOT GRASP IMF SCREW. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVED ONE(1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498519 ↗
• MalfunctionOct 1, 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 DATE THE HOLDING SLEEVE IS NOT PROPERLY HOLDING THE SCREW ANYMORE DUE TO OVERUSE. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) HOLDING SLEEVE. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12564026 ↗
• MalfunctionOct 1, 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 DATE THE HOLDING SLEEVE IS NOT PROPERLY HOLDING THE SCREW ANYMORE DUE TO OVERUSE. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) HOLDING SLEEVE. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12563944 ↗
• MalfunctionOct 1, 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 DATE THE HOLDING SLEEVE IS NOT PROPERLY HOLDING THE SCREW ANYMORE DUE TO OVERUSE. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)HOLDING SLEEVE. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12563934 ↗
• MalfunctionOct 1, 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 DATE THE HOLDING SLEEVE IS NOT PROPERLY HOLDING THE SCREW ANYMORE DUE TO OVERUSE. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) HOLDING SLEEVE. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12563877 ↗
• MalfunctionAug 31, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGICAL HOLDING SLEEVE SPRING WAS MISSING, SO IT WAS NOT LATCHING ON THE SCREWDRIVER. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. THIS REPORT IS FOR A SURGICAL HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393401 ↗
• 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) HOLDING SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10182588 ↗
• MalfunctionMar 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOLDING SLEEVE AND CRUCIFORM SCREWDRIVER WOULD NOT LOCK TOGETHER. THE ISSUE WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: CRUCIFORM SCREWDRIVER (PART NUMBER 313.96, LOT L808139, QUANTITY 1). THIS REPORT INVOLVES ONE HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9890552 ↗
• MalfunctionFeb 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE HOLDING SLEEVE OF THE INTERMAXILLARY FIXATION (IMF) SCREW DID NOT HOLD THE HEAD OF THE SCREWS WELL; WHEN THE SCREWS WERE PLACED THEY MOVE A LOT, MAKING PLACEMENT DIFFICULT. IT WAS NOTED A LOT OF FORCE WAS PLACED ON TWO (2) SELF-DRILLING INTERMAXILLARY FIXATION (IMF) SCREWS TO PLACE THEM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS REPORT IS FOR A HOLDING SLEEVE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377872 ↗
• MalfunctionDec 31, 2018Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING INSTRUMENT INSPECTION IN THE STERILE PROCESSING DEPARTMENT ON AN UNKNOWN DATE, IT WAS NOTED THAT THE HOLDING SLEEVE FOR STQARDRIVE SCREWDRIVER SHAFT AND THE HOLDING SLEEVE WERE NOT FUNCTIONING PROPERLY. IT WAS FURTHER NOTED THAT THE DEVICES ARE MISSING SPRINGS. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE . THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8206938 ↗
• MalfunctionDec 26, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHAFT OF AN UNKNOWN SCREWDRIVER WOULD NOT INTRODUCE INTO THE HOLDING SLEEVE DURING AN ORTHOGNATHIC SURGERY BIMAXILLARY. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196355 ↗
• MalfunctionDec 14, 2018Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, A HOLDING SLEEVE HAD A MISSING SPRING AND WAS NOTED UNUSABLE. NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8164180 ↗
• MalfunctionNov 15, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON OCTOBER 31, 2018, DURING INSPECTION IN THE STERILE PROCESSING DEPARTMENT, IT WAS FOUND OUT THAT THE SCREWDRIVER BLADE SHAFT KEEPS STICKING INSIDE THE HOLDING SLEEVE AND IT DID NOT HAPPENED DURING A CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8075167 ↗
• MalfunctionAug 28, 2018Mechanical Problem; Mechanical Problem

  THIS REPORT IS FOR A VETERINARY CASE. THERE WAS NO HUMAN PATIENT INVOLVEMENT. IT WAS REPORTED THAT ON AN UNKNOWN DATE THE HOLDING SLEEVE WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7824461 ↗