NA 03.632.055Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034719115), received between Feb 22, 2017 and Feb 24, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TIPS ARE WORE OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21452172 ↗
• MalfunctionFeb 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TIPS ARE WORE OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450974 ↗
• MalfunctionFeb 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TIPS ARE WORE OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450946 ↗
• MalfunctionJun 3, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER STRIPPED DURING CROSSLINK INSERTION. THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) STRAIGHT TIP T15 DRIVER- STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595534 ↗
• MalfunctionApr 19, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021, WHEN A TRANSVERSE CONNECTER WAS BEING TIGHTENED BY THE DRIVER SHAFT, ITS TIP BROKE. THE TRANSVERSE CONNECTER WAS FINALLY TIGHTENED BY A REPLACING DRIVER SHAFT. THE PATIENT WAS X-RAYED, AND IT WAS CONFIRMED THAT ALL THE FRAGMENT(S) HAD BEEN REMOVED. ALSO, IT WAS POSTOPERATIVELY FOUND THAT THE TIP OF THE SCREWDRIVER HAD BEEN DEFORMED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) STRAIGHT TIP T15 DRIVER- STANDARD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11687590 ↗
• MalfunctionFeb 24, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE TIP OF THE SCREWDRIVER SHAFT IS WORN OUT. THERE WERE NO FRAGMENTS ARE GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SCRDRIVERSHAFT T15 STD. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375630 ↗
• MalfunctionFeb 24, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE DRIVER IS WORN OUT, THIS COMPLAINT IS FOR ONE (1) SCRDRIVERSHAFT T15 STD. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11374084 ↗
• MalfunctionOct 23, 2020Break; Break

  IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2020, WHEN THE SURGEON WAS TIGHTENING THE SCREW OF THE SNAP-ON TRANSVERSE CONNECTOR USING A T15 STANDARD SCREWDRIVER, THE DISTAL TIP OF THE SCREWDRIVER BROKE OFF. ANOTHER DRIVER WAS SELECTED, AND THE SURGERY CONTINUED AS PLANNED. THE GENERATED FRAGMENTS OF THE BROKEN DEVICE WERE REMOVED EASILY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR A STRAIGHT TIP T15 DRIVER- STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10729470 ↗
• MalfunctionMay 12, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PREOPERATIVELY, THAT THE DRIVER SHAFT WAS FOUND DISTORTED. THE SCREWDRIVER WAS NOT USED DURING THE SPINAL FUSION FRACTURE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) STRAIGHT TIP T15 DRIVER-STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10046391 ↗
• MalfunctionMay 8, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT A MATRIX CROSS LINKS TWISTED TIP DRIVER/SCREWDRIVER SHAFT STARDRIVE T15 STANDARD (STRAIGHT TIP) WAS BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592705 ↗
• MalfunctionFeb 7, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON (B)(6) 2018, SEVERAL INSTRUMENTS FAILED. WHEN INSERTING A TITANIUM CANNULATED SCREW INTO LUMBAR FOUR (L4), THE RATCHET T-HANDLE MADE A CLICKING SOUND AND SLIPPED AGAINST THE T15 DRIVER SHAFT. THE SURGEON DETERMINED IT WOULD NOT WORK AND REQUESTED A DIFFERENT HANDLE. THE SHAFT WAS CHANGED TO ANOTHER T-HANDLE AND SURGEON COMPLETED INSERTING THE SCREWS JUST FINE. THEN, AT THE END OF THE CASE, THE SURGEON SELECTED A TRANS CONNECTOR AND BEGAN LOCKING IT USING THE STANDARD TORQUE LIMITING HANDLE AND STRAIGHT T15 DRIVER SHAFT. THE HANDLE CLICKING AS NORMAL AND TORQUING OUT, THE DRIVER SHAFT BROKE OFF INTO THE RECESS OF THE TRANS CONNECTOR. THE SURGEON REMOVED THE DRIVER SHAFT AND TRANS CONNECTOR THEN REQUESTED ANOTHER DRIVER SHAFT AND TRANS CONNECTOR. OTHER ITEMS WITH SAME PART NUMBER WERE OBTAINED AND TRIED AGAIN. THIS TIME, INSTEAD OF THE TIP BREAKING, THE TIP OF THE SHAFT BEGAN TO DEFORM. SURGEON REQUESTED A THIRD SHAFT AND THE TORQUE LIMITER CLICKED AS IT SHOULD ON ALL THREE (3) SCREWS OF THE TRANS CONNECTOR. SURGERY WAS COMPLETED WITH A THE THREE TO FIVE (3-5) MINUTE DELAY TO GATHER SECONDARY INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316202 ↗
• MalfunctionJan 8, 2019Break; Break

  IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON (B)(6) 2018, SEVERAL INSTRUMENTS FAILED. WHEN INSERTING A TITANIUM CANNULATED SCREW INTO LUMBAR FOUR (L4), THE RATCHET T-HANDLE MADE A CLICKING SOUND AND SLIPPED AGAINST THE T15 DRIVER SHAFT. THE SURGEON DETERMINED IT WOULD NOT WORK AND REQUESTED A DIFFERENT HANDLE. THE SHAFT WAS CHANGED TO ANOTHER T-HANDLE AND SURGEON COMPLETED INSERTING THE SCREWS JUST FINE. THEN, AT THE END OF THE CASE, THE SURGEON SELECTED A TRANSCONNECTOR AND BEGAN LOCKING IT USING THE STANDARD TORQUE LIMITING HANDLE AND STRAIGHT T15 DRIVER SHAFT. THE HANDLE CLICKING AS NORMAL AND TORQUING OUT, THE DRIVER SHAFT BROKE OFF INTO THE RECESS OF THE TRANSCONNECTOR. THE SURGEON REMOVED THE DRIVER SHAFT AND TRANSCONNECTOR THEN REQUESTED ANOTHER DRIVER SHAFT AND TRANSCONNECTOR. OTHER ITEMS WITH SAME PART NUMBER WERE OBTAINED AND TRIED AGAIN. THIS TIME, INSTEAD OF THE TIP BREAKING, THE TIP OF THE SHAFT BEGAN TO DEFORM. SURGEON REQUESTED A THIRD SHAFT AND THE TORQUE LIMITER CLICKED AS IT SHOULD ON ALL THREE (3) SCREWS OF THE TRANSCONNECTOR. SURGERY WAS COMPLETED WITH A THE THREE TO FIVE (3-5) MINUTE DELAY TO GATHER SECONDARY INSTRUMENTS. THERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8226702 ↗
• MalfunctionJan 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON (B)(6) 2018, SEVERAL INSTRUMENTS FAILED. WHEN INSERTING A TITANIUM CANNULATED SCREW INTO LUMBAR FOUR (L4), THE RATCHET T-HANDLE MADE A CLICKING SOUND AND SLIPPED AGAINST THE T15 DRIVER SHAFT. THE SURGEON DETERMINED IT WOULD NOT WORK AND REQUESTED A DIFFERENT HANDLE. THE SHAFT WAS CHANGED TO ANOTHER T-HANDLE AND SURGEON COMPLETED INSERTING THE SCREWS JUST FINE. THEN, AT THE END OF THE CASE, THE SURGEON SELECTED A TRANSCONNECTOR AND BEGAN LOCKING IT USING THE STANDARD TORQUE LIMITING HANDLE AND STRAIGHT T15 DRIVER SHAFT. THE HANDLE CLICKING AS NORMAL AND TORQUING OUT, THE DRIVER SHAFT BROKE OFF INTO THE RECESS OF THE TRANSCONNECTOR. THE SURGEON REMOVED THE DRIVER SHAFT AND TRANSCONNECTOR THEN REQUESTED ANOTHER DRIVER SHAFT AND TRANSCONNECTOR. OTHER ITEMS WITH SAME PART NUMBER WERE OBTAINED AND TRIED AGAIN. THIS TIME, INSTEAD OF THE TIP BREAKING, THE TIP OF THE SHAFT BEGAN TO DEFORM. SURGEON REQUESTED A THIRD SHAFT AND THE TORQUE LIMITER CLICKED AS IT SHOULD ON ALL THREE (3) SCREWS OF THE TRANSCONNECTOR. SURGERY WAS COMPLETED WITH A THE THREE TO FIVE (3-5) MINUTE DELAY TO GATHER SECONDARY INSTRUMENTS. THERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8226657 ↗
• MalfunctionDec 11, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGEON WAS IMPLANTING A TITANIUM SNAP-ON TRANSCONNECTOR USING A STRAIGHT DRIVER AND TORQUE LIMITING HANDLE. WHILE TIGHTENING THE SECOND SCREW OF THE IMPLANT, AND BEFORE THE SURGEON ACHIEVED THE TORQUE LIMIT, THE DRIVER BECAME TWISTED AND DEFORMED AT THE DISTAL END. BECAUSE OF THIS, THE SURGEON WAS NOT ABLE TO ACHIEVE FINAL TIGHTENING. A NEW DRIVER SHAFT WAS OPENED UP AND THEN THE SURGEON WAS ABLE TO FINAL TIGHTEN BOTH THE SECOND AND THIRD SCREW OF THE CROSSLINK. THE SHAFT DEFORMING CAUSED A FOUR (4) MINUTE DELAY WHILE A NEW SHAFT WAS FOUND AND OPENED. SURGERY WAS COMPLETED AS PLANNED AND NO FRAGMENTS SEPARATED OFF OF THE INSTRUMENT. NO PATIENT CONSEQUENCE WAS REPORTED. CONCOMITANT DEVICES: SPINE SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 2), TORQUE LIMITING HANDLE (PART: 03.632.204, LOT: UNKNOWN, QUANTITY: 1), TITANIUM SNAP-ON TRANSCONNECTOR (PART: 04.633.347, LOT: UNKNOWN, QUANTITY: 1). THIS COMPLAINT IS FOR A STRAIGHT TIP T15 DRIVER- STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8150319 ↗
• InjuryFeb 23, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD AN ACCIDENT WITH AN EXPOSED FEMORAL FRACTURE ON (B)(6) 2014. HE UNDERWENT SURGICAL PROCEDURE ON (B)(6) 2014 AND PLATE AND SCREWS WERE IMPLANTED FOR CONSOLIDATION OF THE LESIONS. WHEN THE PATIENT GOT UP FROM THE SOFA ON (B)(6) 2014 THE DYNAMIC COMPRESSION PLATE (DCP) BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. PATIENT OUTCOME IS GOOD AND RECUPERATING FINE. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT REPORTED PARTS: 2X CORTEX SCREW (PART 214.038, LOT 8821520 / 8821521). THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6352830 ↗
• MalfunctionFeb 22, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL LUMBAR FUSION SURGERY ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. PATIENT WAS ORIGINALLY IMPLANTED WITH DEPUY EXPEDIUM RODS/SCREWS AT THE L4-S1 DISC LEVEL. ALSO ONE (1) SNAP-ON SYNTHES MATRIX CROSS LINK IMPLANT WAS USED AT THE L4-L5 DISC LEVEL. PATIENT HAD A FOLLOW-UP PROCEDURE ON (B)(6) 2017 TO REMOVE THE ORIGINAL DEPUY EXPEDIUM CONSTRUCT. REASON FOR THE FOLLOW-UP SURGERY IS UNKNOWN. DURING THE PROCEDURE, WHILE THE SURGEON WAS INSTRUMENT AT THE L4-L5 DISC LEVEL AND AS HE WAS REMOVING THE SYNTHES SNAP-ON MATRIX CROSS LINK TRANSCONNECTOR IMPLANT WITH THE STRAIGHT TIP SCREWDRIVER THE TIP OF THE SCREW DRIVER INSTRUMENT BROKE OFF INTO THE HEAD OF THE TRANSCONNECTOR SCREW. THE FRAGMENT WAS RETRIEVED. SURGEON CHOSE ANOTHER SCREW DRIVER FROM THE INSTRUMENT SET THAT WAS AVAILABLE IN THE OPERATING ROOM. PATIENT WAS REVISED TO NEW EXPEDIUM SCREWS/ROD IMPLANTS. THERE WAS NO DELAY REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT IS REPORTED IN STABLE CONDITION. THIS IS FOR 1 DEVICE CONCOMITANT DEVICES: SNAP-ON MATRIX TRANSCONNECTOR: (ITEM # UNKNOWN. LOT # UNKNOWN, QUANTITY 1EA). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6351586 ↗