NA 03.632.400Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705034719917), received between Jan 6, 2017 and Mar 3, 2025 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2024. DURING REMOVAL OF A SET SCREW OF THE MATRIX, THE TIP OF THE SCREWDRIVER GOT DAMAGED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT IS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505956 ↗
• MalfunctionFeb 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS A CBT-PLIF (L4, LEFT) FOR LUMBAR CANAL STENOSIS ON (B)(6) 2025. THE TIP OF THE SCREWDRIVER SHAFT BROKE OFF WHEN APPLYING TORQUE IN THE FINAL TIGHTENING PROCEDURE. SINCE THERE WAS ANOTHER ONE AS A SPARE, IT WAS USED IN THE SURGERY. THE SURGEON CONFIRMED BY VISUAL INSPECTION AND X-RAYS THAT NO FRAGMENTS REMAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461815 ↗
• MalfunctionSep 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A POSTERIOR FUSION (L4) FOR COMPRESSION FRACTURE OCCURRED ON (B)(6) 2024. IN THE SURGERY, DURING FINAL FASTENING, THE TIP OF THE SCREWDRIVER SHAFT WAS BROKEN WHILE TORQUING OUT. AFTER REMOVING THE FRAGMENTS AND MATCHING THE DRIVER TO THE FRAGMENTS, SEVERAL FRAGMENTS APPEARED TO BE LACKING. THEREFORE, THE SURGICAL FIELD WAS CHECKED AND CLEANED, AND AFTER VISUAL AND IMAGE CONFIRMATION. IT WAS DETERMINED THAT THERE WAS NO REMAINING RESIDUE. THEN ANOTHER SCREWDRIVER SHAFT WAS USED FOR THE FINAL FASTENING AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOTED AS STABLE. THIS REPORT IS FOR ONE STRAIGHT TIP T25 DRIVER STANDARD THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136679 ↗
• MalfunctionJan 4, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON STRIPPED A MATRIX FINAL TIGHTENING SHAFT WHEN FINAL TIGHTENING THE SET CAPS. THIS EVENT DID NOT AFFECT THE PATIENT OR PROCEDURE OUTCOME. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE STRAIGHT TIP T25 DRIVER STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096328 ↗
• MalfunctionDec 27, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION CASE DUE TO EXTENSION OF FUSION, WHERE THE PATIENT REQUIRED L5-S1 FUSION 10 YEARS AFTER THE INITIAL FUSION OF L4-L5 BY THE SAME SURGEON. THE SURGEON¿S PLAN WAS TO REMOVE THE 4 LOCKING CAPS FROM THE PRIMARY CASE, REMOVE THE ROD, INSERT TWO SCREWS IN S1 AND THEN ADD A NEW LONGER ROD, AND PUT IN 6 NEW LOCKING CAPS. AFTER THE FIRST LOCKING SCREW REMOVAL, IT WAS NOTED THAT THE DRIVER SHAFT (USED WITH TORQUE HANDLE) WAS BURRED. THIS WAS REPLACED WITH A NEW SHAFT AND THE CASE WAS COMPLETED AS PLANNED WITHOUT ANY DELAY. NO FRAGMENTS WERE NOTED IN THE PATIENT, AND THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE STRAIGHT TIP T25 DRIVER STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051796 ↗
• MalfunctionDec 27, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PLIF WITH THE MATRIX FOR THE SPINAL STENOSIS ON (B)(6) 2022. THE SCREW AND THE ROD WERE INSERTED AS PER PROCEDURE. DURING FINAL TIGHTENING WITH THE T-HANDLE IN QUESTION, THE SCREWDRIVER SHAFT BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT IS STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT T25 STD STRAIGHT TIP W/HE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050447 ↗
• MalfunctionOct 18, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE INSTRUMENTS WERE CHECKED FOR WEAR AND TEAR PRIOR TO PROCESSING. IT WAS NOTED THAT A FEW INSTRUMENTS WERE WORN AND REQUIRED REPLACEMENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE STRAIGHT TIP T25 DRIVER STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624377 ↗
• MalfunctionMar 29, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, (B)(6) WAS PERFORMING AN L3-5 FUSION WITH BILATERAL PEDICLE SCREWS AND RODS AT EACH LEVEL FROM L3-L5 ALONG WITH TLIF INTERBODIES AT THE DISC SPACES OF L3/4 AND L4/5. (B)(6) PLACED 75MM (5.5 DIAMETER) RODS INTO THE TULIP HEADS AND PROVISIONALLY TIGHTENED EACH SCREW. WHEN HE WAS FINAL TIGHTENING THE SET SCREW AT LEFT L5, THE TIP OF THE STRAIGHT TIP T25 DRIVER STANDARD BROKE OFF. THE BROKEN PIECE WAS REMOVED AND THE DRIVER WAS REMOVED FROM THE STERILE FIELD AND REPLACED WITH A NEW ONE. THERE WERE NO FRAGMENTS LEFT BEHIND, AND THIS DID NOT RESULT IN A DELAY TO THE CASE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THIS COMPLAINT INVOLVES ONE (1) DEVICE STRAIGHT TIP T25 DRIVER STANDARD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13940419 ↗
• MalfunctionFeb 9, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION ON (B)(6) 2022, THE TIP OF THE DRIVER SHAFT BROKE OFF. A FRAGMENT WAS REMOVED FROM THE LESION. ANOTHER DEVICE WAS USED. THE PATIENT WAS X-RAYED, AND IT WAS CONFIRMED THAT NO FRAGMENT WAS LEFT IN THE LESION. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A STRAIGHT TIP T25 DRIVER STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500137 ↗
• MalfunctionFeb 2, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE TREATING LUMBAR SPONDYLOLISTHESIS THE TIP OF THE SCREWDRIVER BROKE OFF DURING FINAL SETSCREW TIGHTENING. NO FRAGMENT WAS LEFT IN THE LESION. PROCEDURE WAS COMPLETED WITH A REPLACEMENT. NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT T25 STD STRAIGHT TIP W/HE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423587 ↗
• MalfunctionOct 13, 2021Material Integrity Problem; Material Integrity Problem

  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 TO TREAT SPONDYLOLISTHESIS. DURING THE PROCEDURE, THE TIP OF THE SCREWDRIVER BROKE OFF DURING FINAL SCREW TIGHTENING. ALL FRAGMENTS ARE REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) UNK ¿ PLATES. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12626981 ↗
• MalfunctionFeb 21, 2020Break; Break

  CONCOMITANT DEVICE REPORTED: MATRIX SPINE LOCKING CAP (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). PEDICLE SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY1). SCRDRIVERSHAFT T25 STD STRAIGHT TIP W/HE (PART NUMBER 03.632.400, LOT L463379, QUANTITY 1). RETAIN-SLEEVE LONG F/MATRIX 5.5 (PART NUMBER 03.632.036, LOT 6946522, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9739149 ↗
• MalfunctionFeb 21, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DISTAL TIP OF TWO SCREWDRIVERS WAS BROKE UPON FINAL TIGHTENING OF THE SCREW. ALL TIP FRAGMENTS WERE RETRIEVED, AND NO PIECES REMAINED IN THE PATIENT. ALSO, A MATRIX THREADED HOLDING SLEEVE DISTAL TIP SHEARED WHEN ATTEMPTING TO RE-ENGAGE THE PEDICLE SCREW, BUT PIECE DID NOT FALL OFF. THE SURGERY WAS COMPLETED WITHOUT ANY DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN MATRIX SPINE LOCKING CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). UNKNOWN PEDICLE SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 01 OF 03 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9739145 ↗
• MalfunctionOct 11, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE MATRIX SCREWDRIVER TIP BROKE OFF WHEN ATTEMPTING TO FINAL TIGHTEN THE SET SCREW. ALL FRAGMENTS GENERATED WERE CAPTURED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9181683 ↗
• MalfunctionMay 24, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2019, THE TIP OF A T25 SCREWDRIVER SHAFT BROKE WHEN THE SURGEON PERFORMED FINAL TIGHTENING OF THE SET SCREW. THE SURGEON CONFIRMED THAT THERE WAS NO BROKEN FRAGMENT LEFT IN THE PATIENT'S BODY UNDER X-RAY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS IN STABLE CONDITION. CONCOMITANT DEVICE: SET SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) T25 SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641835 ↗
• MalfunctionMay 7, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING A POSTERIOR SPINE FUSION SURGERY WITH AN UNKNOWN MATRIX 5.5 SYSTEM AT T8-T11 DUE TO COMPRESSION FRACTURE, WHEN THE SURGEON PERFORMED THE FINAL TIGHTENING OF THE SCREW, THE SCREWDRIVER SHAFT BROKE OFF. THE SURGERY WAS COMPLETED BY USING AN ALTERNATIVE SCREWDRIVER SHAFT. THE SURGEON COMMENTED AND SUSPECTED THAT IT WAS DUE TO A METAL FATIGUE. THERE WAS A LESS THAN THIRTY (30) MINUTES SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER STANDARD . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586955 ↗
• MalfunctionFeb 27, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROUTINE AUDIT OF THE INSTRUMENTS, IT WAS NOTICED THAT THE SCREWDRIVER SHAFT WAS WORN OUT AND VIRTUALLY UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER STANDARD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8374828 ↗
• MalfunctionFeb 26, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT LUMBAR FUSION PROCEDURE, THE STRAIGHT TIP T25 SCREW DRIVER WAS BROKEN AND THE SECOND T25 STARDRIVE WAS ALSO BROKEN WHILE THE DOCTOR WAS TRYING TO LOOSEN THE UNKNOWN SET SCREW. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370171 ↗
• MalfunctionFeb 6, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING MATRIX FINAL TIGHTENING, THE END OF TORQUE SHAFT WAS BROKEN AND THE OTHER TORQUE DID NOT SEEM TO CLICK PROPERLY WITH REPLACEMENT SHAFT EITHER. THERE WERE FRAGMENTS GENERATED FROM A BROKEN DEVICE AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. PROCEDURE OUTCOME WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8311984 ↗
• MalfunctionMar 30, 2018Break; Break

  IT WAS REPORTED THAT DURING A REVISION OF T11-L3 POSTERIOR SPINAL FUSION, EXTENSION TO L5 (PREVIOUSLY DONE IN (B)(6) OF 2017) PERFORMED ON (B)(6) 2018 THERE WERE MULTIPLE DEVICE MALFUNCTIONS. WHEN THE SURGEON WAS TRYING TO REMOVE A SET SCREW SO THAT HE COULD REMOVE THE RODS, THE TIP OF THE T25 DRIVER ATTACHMENT BROKE OFF IN THE SET SCREW. SURGEON ADDED SCREWS AT L4 AND L5 TO CREATE A NEW CONSTRUCT OF T11-L5 WITH BILATERAL PEDICLE SCREW FIXATION AND BILATERAL RODS. AFTER INSERTING ONE OF THE MATRIX PEDICLE SCREWS, IT NOTICED THAT THE THREADED PORTION OF THE DRIVER SLEEVE HAD BECOME WORN AND WAS ABOUT TO BREAK. THIS ITEM WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD AND REPLACED WITH A NEW SLEEVE. AFTER ALL SCREWS AND RODS WERE PLACED, WHEN SURGEON WAS FINAL TIGHTENING THE SET SCREWS USING THE SCREW DRIVER WHEN THE TIP BROKE OFF. THE BROKEN PART WAS RETRIEVED AND THE BROKEN DRIVER WAS REPLACED WITH A NEW ONE AND THE CASE ENDED WITHOUT ANY FURTHER COMPLICATIONS. THERE WAS NO HARM TO THE PATIENT WITH ANY OF THESE ISSUES. CONCOMITANT DEVICE REPORT: SET SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN), RODS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385235 ↗
• MalfunctionFeb 14, 2018Break; Break

  IT WAS REPORTED THE SHAFT OF A STRAIGHT TIP T25 DRIVER STANDARD BROKE WHILE TRYING TO REMOVE A SET SCREW DURING SURGERY. ALL PIECES WERE RECOVERED AND THERE WAS NO PATIENT CONSEQUENCE. ALL AVAILABLE DETAILS HAVE BEEN PROVIDED REGARDING THIS EVENT. CONCOMITANT DEVICE REPORT: [UNKNOWN SET SCREW] (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS COMPLAINT IS FOR ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7270800 ↗
• MalfunctionJan 16, 2018Break; Break

  (B)(6) REPORTED FOLLOWING: IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT PROCEDURE FOR SPINAL FUSION. DURING THE PROCEDURE, WHEN THE SURGEON WAS FINAL TIGHTENING THE MATRIX SET SCREWS, THE TIP OF THE SCREWDRIVER SHAFT BROKE. ALL PIECES WERE RETRIEVED. SURGEON COMPLETED THE FINAL TIGHTENING WITH ANOTHER SCREWDRIVER SHAFT. NO PATIENT HARM WAS REPORTED. THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7195423 ↗
• MalfunctionDec 5, 2017Break; Break

  IT WAS REPORTED THAT PATIENT HAD AN ORIGINAL SURGERY ON AN UNKNOWN DATE AT SPINE DISC LEVELS L3-S1 USING A MATRIX CONSTRUCT FOR A SPINE FUSION. PATIENT WAS ORIGINALLY IMPLANTED WITH TWO (2) MATRIX RODS, EIGHT (8) MATRIX LOCKING SCREWS AND EIGHT (8) MATRIX LOCKING CAPS. ON AN UNKNOWN DATE, POST-OPERATIVELY, PATIENT PRESENT WITH SPINAL STENOSIS AT L2 DISC LEVEL. ON (B)(6) 2017 PATIENT WAS BROUGHT BACK TO SURGERY TO ADDRESS THE PATIENT¿S NEUROLOGICAL DEFICIT AT L2 DISC LEVEL. SURGEON REMOVED THE PREVIOUSLY IMPLANTED TWO (2) MATRIX RODS AND EIGHT (8) LOCKING CAPS. THE ORIGINAL MATRIX LOCKING SCREWS WERE IN GOOD BONE PLACEMENT. SURGEON IMPLANTED TWO NEW MATRIC LOCKING SCREWS AT THE L2 DISC LEVELS. TWO (2) NEW RODS AND TEN (10) LOCKING CAPS WERE ALSO IMPLANTED. (THIS EVENT CAPTURED ON UNITY COMPLAINT (B)(4)). ALSO, DURING THE REVISION PROCEDURE AS THE SURGEON WAS DOING THE FINIAL TIGHTENING AT THE LEFT S1 DISC LEVEL, THE TIP OF THE SCREWDRIVER INSTRUMENT BROKE OFF INSIDE THE HEAD OF THE SCREW. SURGEON REMOVED THE TIP SCREWDRIVER FRAGMENT FROM THE HEAD OF THE SCREW WITH NO ISSUES AND PROCEEDED WITH THE SURGERY. ANOTHER SCREWDRIVER WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE REVISI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7082625 ↗
• MalfunctionOct 23, 2017Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A LUMBAR SPINAL FUSION ON (B)(6) 2017, THE DISTAL TIP OF TWO SCREWDRIVER SHAFTS WERE DAMAGED WHEN A SURGEON ATTEMPTED TO REMOVE A SET SCREW (LOCKING CAP) FROM THE HEAD OF A POLYAXIAL MATRIX SCREW TO ADJUST THE POLYAXIAL MATRIX SCREW AFTER IT HAD BEEN FINAL TIGHTENED. ONE OF THE SCREWDRIVER SHAFTS BROKE INTO TWO OR THREE PIECES, AND THE OTHER ONE BECAME BENT. THERE WERE NO FRAGMENTS OF THE BROKEN SCREWDRIVER LEFT IN THE PATIENT, AND ALL PIECES WILL BE RETURNED. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A LIKE INSTRUMENT. REPORTED CONCOMITANT DEVICES: POLYAXIAL MATRIX SCREW: (QTY. 1). MATRIX LOCKING CAP (PART # 04.632.000, QTY.1). THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER STANDARD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6969109 ↗
• MalfunctionSep 19, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT A T10-PELVIS MATRIX HARDWARE REVISION. AT THE END OF THE CASE, WHILE STILL IN THE OPERATING ROOM, THE SURGICAL INSTRUMENTS THAT WERE USED IN THE PROCEDURE WERE INSPECTED AND IT WAS NOTED THAT THE MATRIX HEAD POP-ON TOOL, THE MATRIX T25 STRAIGHT SHAFT AND THE MATRIX LONG HOLDING SLEEVE WERE DAMAGED. THE TOP OF THE MATRIX HEAD POP-ON TOOL (THE SILVER PART THAT SCREWS INTO THE GREEN HANDLE) WAS BENT. ADDITIONALLY, THE TIP OF THE MATRIX T25 STRAIGHT SHAFT WAS MANGLED AND UNUSABLE FOR THE NEXT CASE AND THE MATRIX LONG HOLDING SLEEVE HAD A PORTION OF THE TOP THREAD MISSING FROM THE TIP. REPORTEDLY, THERE WERE NO BROKEN PIECES OF THE DEVICE LEFT IN THE PATIENT AT THE END OF THE CASE. THIS WAS CONFIRMED BY A FINAL X-RAY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION AND WITHOUT ANY SURGICAL DELAYS. IT WAS REPORTED THAT THERE WERE NO UNANTICIPATED X-RAYS REQUIRED. PATIENT OUTCOME IS GOOD. REVISION PROCEDURE IS CAPTURED IN (B)(4). THIS REPORT ADDRESSES THE INTRAOPERATIVE EVENTS. THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6877939 ↗