USS 03.602.042Recalls & reported problems
Synthes GmbH · 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes torque limiting wrench is a surgical hand tool used with dual-opening USS spinal instrumentation sets. The 29 reports all describe calibration and torque testing problems — handles measuring outside specification and failing torque tests — typically found during routine inspection of loaner sets, with no patient involved. No deaths or injuries were reported, and 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705034712277), received between Jan 16, 2020 and Oct 3, 2024 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Calibration Problem” (29 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
- Calibration Problem29
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Patient Involvement3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2024Calibration Problem; Calibration Problem
THE FOLLOWING ITEM FAILED FOR TORQUE TESTING ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT INVOLVES ONE 12NM TORQ LIMITING WRENCH F/ DUAL-OP USS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20360573 ↗MalfunctionSep 6, 2024Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AUGUST 9, 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157641 ↗MalfunctionSep 6, 2024Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON (B)(6) 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157144 ↗MalfunctionAug 26, 2024Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON JULY 30, 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL , IT WAS OBSERVED THAT THE T-HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION TORQUE TESTED LOW. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20071454 ↗MalfunctionDec 28, 2023Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE DISTRIBUTION CENTER, IT WAS OBSERVED THAT THE TORQUE LIMITING WRENCH WAS OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED LOW. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18415923 ↗MalfunctionNov 24, 2023Calibration Problem; Calibration Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT FOLLOWING ITEM DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING. ITEM REMOVED FROM SET BELOW AND WILL BE DELIVERED TO MAILROOM FOR DELIVERY TO PQS ROOM. THIS REPORT IS FOR ONE (1) 12NM TORQ LIMITING WRENCH F/ DUAL-OP USS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18205091 ↗MalfunctionNov 28, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE 12NM TORQ LIMITING WRENCH F/ DUAL-OP USS HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 12NM TORQ LIMITING WRENCH F/ DUAL-OP USS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15870111 ↗MalfunctionNov 23, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED THAT DURING EVALUATION ON AN UNKNOWN DATE, THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. THE ISSUE WAS FOUND DURING TESTING AT SERVICE AND REPAIR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15851255 ↗MalfunctionOct 25, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING EVALUATION, THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. THE ISSUE WAS FOUND DURING TESTING AT SERVICE AND REPAIR. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15665428 ↗MalfunctionOct 21, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING EVALUATION, THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. THIS WAS DISCOVERED DURING TESTING AT SERVICE AND REPAIR. THIS REPORT INVOLVES ONE 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15651976 ↗MalfunctionSep 15, 2022Calibration Problem; Calibration Problem
DURING TESTING AT SERVICE AND REPAIR. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS . THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15426161 ↗MalfunctionMay 24, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED BY THE SALES REP THAT DURING IN-HOUSE SERVICE REPAIR AND EVALUATION, IT WAS DETERMINED THAT THE TORQUE LIMITING HANDLE DEVICE FAILED CALIBRATION. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14488933 ↗MalfunctionMay 18, 2022Calibration Problem; Calibration Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING EVALUATION AT SERVICE AND REPAIR, THE 112NM TORQ LIMITING WRENCH F/ DUAL-OP USS HAS FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE 12NM TORQ LIMITING WRENCH F/ DUAL-OP USS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14427293 ↗MalfunctionApr 19, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED THAT A 12NM TORQ LIMITING WRENCH F/ DUAL-OP USS DEVICE HAS FAILED CALIBRATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS REPORT IS FOR THE LIMITING WRENCH THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14142504 ↗MalfunctionJan 27, 2022Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE 12NM TORQUE LIMITING WRENCH FOR DUAL-OP USS WAS FOUND TO HAVE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TORQUE LIMITING WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13366460 ↗MalfunctionNov 10, 2021Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON (B)(6) 2021, DURING EVALUATION AT SERVICE AND REPAIR, THE DEVICE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12786957 ↗MalfunctionAug 26, 2021Calibration Problem; Calibration Problem
IT WAS REPORTED THAT DURING THE EVALUATION, THE TECHNICIANS FOUND OUT THAT THE DEVICE FAILED ITS CALIBRATION. THE ISSUE WAS FOUND DURING TESTING AT THE SERVICE AND REPAIR. NO PATIENT INVOLVEMENT, NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12374908 ↗MalfunctionAug 23, 2021Calibration Problem; Calibration Problem
IT WAS REPORTED THAT, DURING TESTING AT SERVICE AND REPAIR, A TORQUE LIMITING HANDLE FAILED IN CALIBRATION. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS CLOSE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12356196 ↗MalfunctionMay 6, 2021Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON (B)(6) 2021, DURING EVALUATION AT SERVICE AND REPAIR, THE TORQUE LIMITING WRENCH WAS FOUND TO HAVE FAILED HIGH. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES 1 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11784963 ↗MalfunctionMay 4, 2021Calibration Problem; Calibration Problem
IT WAS REPORTED THAT DURING TESTING AT SERVICE AND REPAIR, A 12NM TORQUE-LIMITING WRENCH FOR DUAL-OPENING USS FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING UNIVERSAL SPINE SYSTEM (USS). THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11772694 ↗MalfunctionFeb 16, 2021Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON (B)(6) 2021, DURING EVALUATION THE REPAIR TECHNICIANS FOUND OUT THAT THE 12NM TORQUE LIMITING HANDLE QUICK FOR DUAL-OPENING USS WAS FAILED CALIBRATION. THE ISSUE FOUND DURING TESTING AT SERVICE AND REPAIR. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11333175 ↗MalfunctionJan 12, 2021Calibration Problem; Calibration Problem
IT WAS REPORTED ON (B)(6) 2020, DURING TESTING AT SERVICE AND REPAIR IT WAS FOUND THAT 12NM TORQUE-LIMITING WRENCH FOR DUAL-OPENING USS FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11155555 ↗MalfunctionDec 23, 2020Calibration Problem; Calibration Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, TWO (2) TORQUE LIMITING HANDLES DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11065274 ↗MalfunctionDec 23, 2020Calibration Problem; Calibration Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, TWO (2) TORQUE LIMITING HANDLES DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 12MM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11065213 ↗MalfunctionDec 16, 2020Calibration Problem; Calibration Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE TORQUE WRENCH FAILED CALIBRATION. THIS REPORT IS FOR 1 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11022803 ↗
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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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