NA 698340694Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034466743), received between Oct 30, 2018 and Jul 1, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 1, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2025. SEVERAL INSTRUMENTS WERE TAKEN OUT OF CIRCULATION AT THE HOSPITAL DUE TO TYPICAL WEAR AND TEAR OVERTIME. THE INSTRUMENTS WERE REPLACED WITH NEW ONES. THERE WAS NO REPORTED SURGICAL DELAY OR PATIENT CONSEQUENCE. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371135 ↗
• MalfunctionMay 4, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT WHILE INSERTING SOME VERY LONG EXPEDIUM POLYAXIAL SCREWS INTO THE ILIAC CREST/SACRAL AREA DURING SPINE SURGERY, (9X80MM & 10X100MM) THE TIPS OF TWO SCREWDRIVERS STRIPPED AND BROKE DUE TO THE SHEER FORCE REQUIRED TO INSERT THEM INTO THE BONE. THE SURGEON WAS STILL ABLE TO ADVANCE THE SCREW USING A SMALL ROD INSERTED INTO THE HEAD OF THE IMPLANT AND SECURED WITH A SET SCREW ALONG WITH AN ANTI-TORQUE SLEEVE WHICH HELPED ROTATE THE SCREW FORWARD BY FORCING THE ROD AROUND. SURGERY WAS DELAYED 10MIN DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) QUICK CONNECT SI POLYDRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868316 ↗
• MalfunctionFeb 22, 2023Break; Break

  THE TIMING OF THE REPORTED EVENT WAS POSTOPERATIVE. THE PATIENT WAS NOT AFFECTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16422825 ↗
• MalfunctionJun 30, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6), 2022, THAT THE SCREW DRIVER TIP BROKE OFF INSERTING PEDICLE SCREW. PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN. THIS REPORT IS FOR ONE (1) QUICK CONNECT SI POLYDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14874495 ↗
• MalfunctionJun 30, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE SCREW DRIVER TIP BROKE OFF INSERTING PEDICLE SCREW. PATIENT STATUS/ OUTCOME / CONSEQUENCES IS UNKNOWN. THIS REPORT IS FOR ONE (1) QUICK CONNECT SI POLYDRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14874493 ↗
• MalfunctionJun 3, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOSPITAL HAS PUT ASIDE VARIOUS EXPEDIUM INSTRUMENTS THAT WERE STARTING TO SHOW WEAR AND TEAR FROM LONG TERM USE. THE INSTRUMENTS WERE TAKEN FROM SETS AND OUT OF CIRCULATION IF DEEMED NO LONGER USABLE DUE TO BENDS, BREAKAGE, MALFORMATION, STRIPPING ETC. THERE HAVE BEEN NO ADVERSE EVENTS OR IMPACT TO THE PATIENT WITH THESE INSTRUMENTS. THIS REPORT INVOLVES ONE (1) MODIFIED INSTRUMENT SINGLE INNIE POLYAXIAL SCREWDRIVER T20. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597239 ↗
• MalfunctionApr 23, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SURGEON NOTICED THAT THE EXPEDIUM HEXALOBE DRIVER (INTERMEDIATE TIGHTENER) WAS SLIGHTLY BENT AFTER SURGERY. ALSO, A POLY SCREWDRIVER TIP WAS STRIPPED ALONG WITH THE THREADS OF THE SCREWDRIVER THAT ATTACH TO THE HEAD OF THE SCREWS. THERE WAS NO DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) QUICK CONNECT SI POLYDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11719704 ↗
• MalfunctionSep 4, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS INSERTING AN EXPEDIUM POLYAXIAL SCREW IN THE POSTERIOR THORACIC REGION OF THE SPINE WHEN HE NOTICED THE TIP OF THE SCREWDRIVER WAS STRIPPED AND IT WAS BECOMING INCREASINGLY DIFFICULT TO PROPERLY TURN THE SCREWDRIVER AND INSERT THE SCREW. UPON CLOSER OBSERVATION, THE HEX END OF THE SCREW-DRIVER WAS BECOMING STRIPPED. THE LINES ON THE HEX END TIP OF THE SCREWDRIVER WERE BENT AND NOT UNIFORM. THE INSTRUMENT IN QUESTION IS A CUSTOM SHORT QUICK CONNECT POLYAXIAL SCREWDRIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER QUICK CONNECT SCREWDRIVER. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: EXPEDIUM POLYAXIAL SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR ONE (1) QUICK CONNECT SI POLYDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10495080 ↗
• InjuryOct 30, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ON WEDNESDAY, (B)(6) DURING SURGERY, THE (B)(6) HOSPITAL SCRUB NURSE TRIED TO LOAD AN EXPEDIUM PEDICLE SCREW ONTO A CUSTOM EXPEDIUM 5.5MM SHORT SI POLYAXIAL SCREWDRIVER (DS698340694) AND NOTICED THAT IT WAS DIFFICULT TO LOAD THE SCREW. UPON FURTHER INVESTIGATION, SHE NOTICED THAT THE BOTTOM THREAD OF THE SCREWDRIVER WAS MISSING AND THAT IT HAD POTENTIALLY SHEERED OFF. IT IS OUR BELIEF THAT THIS DID NOT HAPPEN DURING THE SURGERY AS THE SCREWDRIVER HAD NOT BEEN USED YET, BUT RATHER AT SOME POINT PRIOR TO THE CASE AND WENT UNNOTICED. THE SCREWDRIVER WAS SET ASIDE AND A SECOND, IDENTICAL SCREWDRIVER WAS USED APPROPRIATELY FOR THE REMAINDER OF THE CASE. THIS DID NOT CAUSE A SIGNIFICANT DELAY TO THE SURGERY (MAYBE 2 MIN). THIS ALSO DID NOT CAUSE ANY UNDUE HARM TO THE PATIENT (NO ADVERSE EVENTS OCCURRED). THE SCREWDRIVER IN QUESTION HAS BEEN WASHED AND WILL BE RETURNED TO DEPUY SYNTHES FOR FURTHER INVESTIGATION. A REPLACEMENT SCREWDRIVER WILL ALSO NEED TO BE ISSUED TO THE HOSPITAL. PATIENT CONSEQUENCE? : NO. PATIENT CONSEQUENCE DESCRIPTION:NO CONSEQUENCE TO THE PATIENT OCCURRED DUE TO THIS INCIDENT. ACTION TAKEN FOR PROCEDURE:A SECOND IDENTICAL SCREWDRIVER WAS USED APPROPRIATELY DURING SU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8020920 ↗