Matrix 03.632.002Recalls & reported problems
Synthes GmbH · T25 STARDRIVE SHAFT F/MATRIX STANDARD · Class 1
All models of Matrix (80)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes Matrix screwdriver is used to tighten screws during procedures. The 56 reports mostly describe the shaft stripping, wearing down, bending, or breaking; they include 1 injury and no deaths. No recalls name this device, and reports increased from 0 in the previous 12 months to 2 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10705034718675), received between Jan 20, 2017 and Apr 30, 2026 — classified as 1 injury, 55 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (20 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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem20
- Dull, Blunt13
- Break10
- Material Twisted/Bent9
- Material Deformation3
- Naturally Worn3
- Peeled/Delaminated3
- Compatibility Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient14
- No Known Impact Or Consequence To Patient12
- No Patient Involvement9
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Material Integrity Problem
IT WAS REPORTED DURING A PROCEDURE DURING FINAL TIGHTENING THE ANTI TORQUE WAS NOT FULLY SEATED THEREFORE THE T25 DRIVER STRIPPED. ANOTHER DEVICE WAS USED. NO SURGICAL DELAY OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048571 ↗MalfunctionNov 21, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2025 UPON POST OPERATIVE INSPECTION THE SCREWDRIVERS WERE NOTED TO BE STRIPPED AND BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23621607 ↗MalfunctionDec 21, 2023Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED DURING A MATRIX REMOVAL PROCEDURE THE CAPS WERE DIFFICULT TO REMOVE AND TWO (2) SCREWDRIVER SHAFTS WERE STRIPPED. A THIRD SHAFT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT. THIS REPORT IS FOR A SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 2 FOR PC-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18376200 ↗MalfunctionMay 19, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED, THAT ON (B)(6) 2023, DURING A POST CASE INSPECTION. EXCESSIVE WEAR WAS NOTED ON SCREWDRIVERS. NO PATIENT OR SURGERY INVOLVED. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 6 OF 8 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16968308 ↗MalfunctionMay 18, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON MAY 3, 2023, DURING A POST CASE INSPECTION, EXCESSIVE WEAR WAS NOTED ON SCREWDRIVERS. NO PATIENT OR SURGERY INVOLVED. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16954324 ↗MalfunctionMay 18, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2023, DURING A POST CASE INSPECTION, EXCESSIVE WEAR WAS NOTED ON SCREWDRIVERS. NO PATIENT OR SURGERY INVOLVED. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16954288 ↗MalfunctionMay 18, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2023, DURING A POST CASE INSPECTION, EXCESSIVE WEAR WAS NOTED ON SCREWDRIVERS. NO PATIENT OR SURGERY INVOLVED. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16954286 ↗MalfunctionMay 18, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2023, DURING A POST CASE INSPECTION, EXCESSIVE WEAR WAS NOTED ON SCREWDRIVERS. NO PATIENT OR SURGERY INVOLVED. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16954284 ↗MalfunctionMay 18, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2023, DURING A POST CASE INSPECTION, EXCESSIVE WEAR WAS NOTED ON SCREWDRIVERS. NO PATIENT OR SURGERY INVOLVED. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16954280 ↗MalfunctionMay 18, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2023, DURING A POST CASE INSPECTION, EXCESSIVE WEAR WAS NOTED ON SCREWDRIVERS. NO PATIENT OR SURGERY INVOLVED. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16954278 ↗MalfunctionMay 18, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6)2023, DURING A POST CASE INSPECTION, EXCESSIVE WEAR WAS NOTED ON SCREWDRIVERS. NO PATIENT OR SURGERY INVOLVED. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 2 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16954274 ↗MalfunctionAug 18, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2022, THAT A FEW PRODUCTS WERE FOUND DAMAGED IN BETH ISRAEL: PLYMOUTH WHEN GOING THROUGH STERILE PROCESSING DEPARTMENT. THOSE WHO ARE MANAGING IT AND WE WANT TO GET THESE DAMAGED PRODUCTS REPLACED AS THEY BEGIN TAKING OVER THE BUSINESS THERE. TIP OF T25 STARDRIVE SHAFT F/MATRIX STANDARD IS SLIGHTLY STRIPPED AND WILL NOT PROPERLY INTERFACE WITH A SCREW. HOLDING SLEEVE-LONG FOR MATRIX'S TIP IS SHEARED OFF. THE LOCATION OF THE SHEARED OFF TIP IS UNKNOWN. PATIENT INFORMATION WAS NOT COLLECTED, INSTRUMENTS FOUND IN SPD. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15253529 ↗MalfunctionNov 3, 2021Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021 DURING AN UNKNOWN PROCEDURE, TWO (2) SCREWDRIVER SHAFTS WERE STRIPPED DURING FINAL TIGHTENING. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER INSTRUMENT TO TIGHTEN THE LOCKING CAPS TO ENSURE THE CONSTRUCT WAS RIGID. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12746358 ↗MalfunctionOct 15, 2021Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A CBT PLIF (L4/5) FOR TREATING LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2021. THE SCREWDRIVER MADE CRACKING NOISE DURING FINAL SCREW TIGHTENING. THE SURGEON COMPLETED THE TIGHTENING WITH THE SCREWDRIVER IN QUESTION. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. IT WAS POSTOPERATIVELY FOUND THAT THE TIP OF THE SCREWDRIVER HAD CHIPPED. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE THIS REPORT IS FOR (1) SCRDRIVERSHAFT T25 STD F/MATRIX 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12638645 ↗MalfunctionJul 5, 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 PLIF TREATING LUMBAR SPONDYLOLISTHESIS SURGERY. DURING THE SURGERY, THE SURGEON WHILE INSERTING A SCREW WITH THE SLEEVE, THE TIP OF THE SLEEVE FOUND CHIPPED. ALSO, ANOTHER TIP BREAKAGE WAS FOUND ON THE REPLACED SLEEVE. THE SURGERY WAS COMPLETED LESS THAN 30-MINUTES DELAY. THERE WERE NO FRAGMENTS ARE REMAINING IN THE PATIENT. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 2). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS REPORT IS 4 OF 4 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12116731 ↗MalfunctionJul 5, 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 PLIF TREATING LUMBAR SPONDYLOLISTHESIS SURGERY. DURING THE SURGERY, THE SURGEON WHILE INSERTING A SCREW WITH THE SLEEVE, THE TIP OF THE SLEEVE FOUND CHIPPED. ALSO, ANOTHER TIP BREAKAGE WAS FOUND ON THE REPLACED SLEEVE. THE SURGERY WAS COMPLETED LESS THAN 30-MINUTES DELAY. THERE WERE NO FRAGMENTS ARE REMAINING IN THE PATIENT. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 2). THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS REPORT IS 3 OF 4 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12116718 ↗MalfunctionJun 21, 2021Material Integrity Problem; Material Integrity Problem
ADDITIONALLY, UPON TIGHTENING A PARALLEL CONNECTER, A T15 SCREWDRIVER WAS ALSO STRIPPED. THIS IS REPORT 3 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12034741 ↗MalfunctionApr 26, 2021Compatibility Problem; Compatibility 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 POSTERIOR SPINAL FUSION AT S1 LEFT TREATING SPONDYLOLISTHESIS. DURING THE SURGERY, THE SCREW WAS NOT ABLE TO BE TIGHTENED. THE SURGEON RETRIED TO CONNECT THE SCREW AND THE SCREWDRIVER OUT OF THE LESION, WHICH WAS FAILED. A CHIPPED FRAGMENT FOUND AFTER POSTOPERATIVE STERILIZATION. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30 MINUTES DELAY. THE PATIENT CONDITION WAS STABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS REPORT IS 2 OF 3 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11727478 ↗MalfunctionMar 16, 2021Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SPONDYLODESIS REVISION PROCEDURE PERFORMED ON (B)(6) 2020, THE ORTHO KIT "MATRIX 5.5 PREASSEMBLED " INSTRUMENTS WERE USED. DURING THE PROCEDURE THE MATRIX LOCKING CAPS WERE CLOSED WITH THE STRAIGHT TIP T25 DRIVER-LONG. HOWEVER THE AREA OF THE DRIVER AT THE CONNECTION TO THE MATRIX LOCKING CAP BROKE. THE BROKEN FRAGMENT WAS ABOUT 3MM LONG, WHICH COULD EASILY BE REMOVED WITH TWEEZERS. THEN THE T25 STARDRIVE SHAFT FOR MATRIX STANDARD WAS USED AS AN ALTERNATIVE INSTRUMENT. THE REMAINING LOCKING CAPS COULD BE LOCKED WITH THIS INSTRUMENT, BUT THE INSTRUMENT WAS UNUSABLE AT THE END BECAUSE THE STAR DRIVE PROFILE OF THE DRIVE OF THIS SCREWDRIVER WAS WORN OUT. THIS ASSESSMENT WAS DONE BY TESTING A LOCKING CAP THAT WAS ALREADY LOCKED WITH TORQUE AND SUBSEQUENTLY CONFIRMED. ADDITIONALLY THERE WAS A ISSUE WITH TWO (2) TORQUE HANDLES. THE TORQUE HANDLES WERE SO DIFFICULT TO MOVE THAT IT WAS IMPOSSIBLE FOR THESE INSTRUMENTS TO GUARANTEE THE SPECIFIED TORQUE LIMIT OF 10 NM. PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE SURGERY WAS NOT DELAYED. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX ST
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11497599 ↗MalfunctionDec 18, 2020Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PERFORMED ON (B)(6) 2020, THE SURGEON FELT SOMETHING DIFFERENT FROM USUAL MANNER DURING SCREW INSERTION. AS SURGEON WAS INSERTING THE SCREW, HE HEARD LITTLE NOISE, AND HE FINALLY FOUND THAT THE THREADS OF THE SLEEVE HAD CHIPPED. HE CONFIRMED VISUALLY AND BY X-RAY THAT NO FRAGMENT WAS LEFT IN THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH LESS THAN THIRTY (30) MINUTES SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: LOCKING/SET SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11036867 ↗MalfunctionSep 11, 2020Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A MATRIX MIS COMBINED WITH A REGULAR MATRIX CASE ON (B)(6) 2020, ISSUES OCCURRED FOR INSERTING THE CAPS (WHERE ALL OF THE SHAFT AND SPORTS GRIP SHAFT WERE NO LONGER HOLDING THE SET SCREW) AS THE DISTAL END TIP WAS DAMAGED/ SLIGHTLY STRIPPED. ALSO, DURING THE FINAL TIGHTENING, THE CANNULATED AND REGULAR LONG SHAFT STRIPPED AT THE DISTAL END TIP. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A STARDRIVE SHAFT. THIS IS REPORT 2 OF 4 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10521073 ↗MalfunctionJun 5, 2020Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE TIP OF THE SCREWDRIVER SHAFT BROKE OFF WHILE PERFORMING FINAL TIGHTENING. THERE WAS NO REPORTED SURGICAL DELAY. FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: T-HANDLE W/RATCHET-WRENCH (PART NUMBER 03.620.061, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10122875 ↗MalfunctionApr 1, 2020Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE THE SCREWDRIVER SHAFT F/MATRIX STANDARD WAS DAMAGED AND STRIPPED FROM THE TIP. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9910344 ↗MalfunctionJul 10, 2019Material Deformation; Material Deformation
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE. DURING THE PROCEDURE, WHILE THE DOCTOR WAS DOING THE FINAL TIGHTENING ON THE MATRIX LOCKING CAPS, THE DOCTOR STRIPPED THE TWO (2) SCREWDRIVER SHAFTS AT THE DISTAL END TIP. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN MATRIX LOCKING CAPS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8775456 ↗MalfunctionJun 14, 2019Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF AN UNKNOWN MATRIX SCREW AT THE LUMBAR DUE TO LOOSENING OF THE SCREW. DURING THE SURGERY, WHEN THE SURGEON TRIED TO REMOVE THE SCREW, THE SCREWDRIVER SHAFT STARDRIVE T25 TIP BROKE OFF. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THERE WERE NO BROKEN PARTS REMAINING IN THE PATIENT'S BODY, CONFIRMED BY X-RAY. THERE WAS LESS THAN 30 MINUTES OF SURGICAL DELAY BUT NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED. CONCOMITANT DEVICES: MATRIX SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A T25 STARDRIVE SHAFT FOR MATRIX STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4) AND CAPTURES THE INTRAOPERATIVE EVENT. THE LOOSENING OF THE UNKNOWN MATRIX SCREW IS CAPTURED UNDER (B)(4).
Patient problems: Not Applicable
MAUDE report 8700127 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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