MatrixMIDFACE 03.503.203Recalls & reported problems
Synthes GmbH · MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/96MM · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes MatrixMIDFACE screwdriver is a surgical instrument used to place screws in facial bone. The 62 reports mostly describe the shaft twisting or bending, blades that no longer grip screws and appear worn out, breakage, and fit problems with other instruments or implants. Most reports involved no patient harm, and there were no deaths and no injuries. No recalls name this device.
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
- 63
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10887587012520), received between Mar 27, 2017 and Sep 14, 2026 — classified as 63 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (43 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent43
- Device-Device Incompatibility16
- Break11
- Failure To Adhere Or Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- Hemorrhage/Blood Loss/Bleeding2
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763271 ↗MalfunctionDec 3, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704471 ↗MalfunctionDec 3, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704454 ↗MalfunctionDec 3, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704449 ↗MalfunctionDec 3, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704440 ↗MalfunctionDec 3, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704408 ↗MalfunctionDec 3, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704401 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704335 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704329 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704320 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704311 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704301 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704298 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704282 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704280 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704274 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THE BLADES ARE NOT HOLDING SCREWS AND APPEAR WORN OUT. NO PATIENT INVOLVEMENT. (B)(4) IS RELATED TO (B)(4). (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS FROM INITIAL (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704272 ↗MalfunctionOct 28, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT ORAL SURGERY ON (B)(6) 2025. SCREWDRIVER DID NOT PICK UP SCREWS AND NEEDED TO BE REPLACED. NO DELAY TO SURGERY; SCREWDRIVER WAS SWAPPED FOR A SLIGHTLY SHORTER SCREWDRIVER SHAFT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406213 ↗MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN (B)(6) 2025, SCREWDRIVER BLADES WORN AFTER MULTIPLES USES IN FIELD. THE SCREWDRIVER BLADES FROM FIELD INVENTORY SETS NEEDS REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22639562 ↗MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN (B)(6) 2025, SCREWDRIVER BLADES WERE WORN AFTER MULTIPLES USES IN FIELD. THE SCREWDRIVER BLADES FROM THE FIELD INVENTORY SETS NEEDS REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22637463 ↗MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN (B)(6) 2025, SCREWDRIVER BLADES WERE WORN AFTER MULTIPLES USES IN FIELD. THE SCREWDRIVER BLADES FROM THE FIELD INVENTORY SETS NEEDS REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22637445 ↗MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN (B)(6) 2025, SCREWDRIVER BLADES WERE WORN AFTER MULTIPLES USES IN FIELD. THE SCREWDRIVER BLADES FROM THE FIELD INVENTORY SETS NEEDS REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22637249 ↗MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN (B)(6) 2025, SCREWDRIVER BLADES WERE WORN AFTER MULTIPLES USES IN FIELD. THE SCREWDRIVER BLADES FROM THE FIELD INVENTORY SETS NEEDS REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22637244 ↗MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN (B)(6) 2025, SCREWDRIVER BLADES WERE WORN AFTER MULTIPLES USES IN FIELD. THE SCREWDRIVER BLADES FROM THE FIELD INVENTORY SETS NEEDS REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22637231 ↗MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN (B)(6) 2025, SCREWDRIVER BLADES WORN AFTER MULTIPLES USES IN FIELD. THE SCREWDRIVER BLADES FROM FIELD INVENTORY SETS NEEDS REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22637058 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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