NA 03.130.270Recalls & reported problems
Synthes GmbH · PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes surgical plate cutter is a heavy-duty cutting plier used to trim bone plates to the right length during surgery. Most of the 35 reports describe the tool breaking or cracking while cutting a plate, sometimes leaving the tip in two pieces, with a few mentioning contamination or corrosion; no deaths and no injuries were reported, and in the described cases no fragments were left in the patient. There are no recalls for 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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886982075468), received between Sep 12, 2018 and Jan 27, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Break” (31 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.
Reports received per month
Most reported problems
Device problems
- Break31
- Contamination /Decontamination Problem1
- Corroded1
- Crack1
- Material Integrity Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Consequences Or Impact To Patient6
- Insufficient Information4
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY WITH VA-HAND FOR PHALANGEAL FRACTURES. DURING THE SURGERY, THE PRODUCT IN QUESTION BROKE OFF WHILE CUTTING THE PLATE. THE PLATE WAS CUT USING HOSPITAL-OWNED PIN CUTTER. THERE WAS NO HARMFUL EFFECT ON THE PATIENT, AND NO BROKEN FRAGMENTS WERE FOUND INSIDE THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192833 ↗MalfunctionJul 21, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22559926 ↗MalfunctionApr 3, 2025Break; Break
IT WAS REPORTED THAT WHEN THE SURGEON WAS ATTEMPTING TO REDUCE IN LENGTH A 2.0 PLATE FOR THE SECOND TIME AS PLATE LENGTH HAD TO BE ADJUSTED AGAIN. WHEN ATTEMPTING TO CUT THE PLATE THE TOP OF THE CUTTER SHEARED OFF, LEAVING THE CUTTER IN TWO PARTS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762909 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2025, A CUTTER TIP WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 21183067 ↗MalfunctionJan 16, 2025Break; Break
IT WAS REPORTED THAT A PLATE CUTTER BROKE DURING A PROCEDURE WHILE CUTTING A 2.0MM PLATE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21170062 ↗MalfunctionOct 24, 2024Break; Break
IT WAS REPORTED THAT THE CUTTING PLIERS FROM CONSIGNED VA HAND SET BROKE WHILE CUTTING PLATE. ALTERNATIVE CUTTERS IN SET WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20526026 ↗MalfunctionOct 14, 2024Break; Break
IT WAS REPORTED THAT A BREAKAGE OF CUTTER OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20445359 ↗MalfunctionOct 9, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS WITH THE PLATE CUTTER IN QUESTION FOR THE FIFTH METATARSAL BONE. WHEN CUTTING THE PLATE, THE PLATE CUTTER IN QUESTION WAS DAMAGED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE AGENT WAS CONCERNED THE STRENGTH OF THE PRODUCT WHEN IT WAS DAMAGED IN THIS WAY, EVEN THOUGH IT WAS WITHIN THE SCOPE OF THE PROPER USE. THE PRODUCT HAS BEEN PURCHASED IN MARCH 2021. ACCORDING TO THE RECORD OF THE AGENT, THE PLATE CUTTER IN QUESTION HAS BEEN USED FOR 60 TIMES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409344 ↗MalfunctionJul 23, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 THE PRODUCT BROKE DURING SURGERY. IT DID NOT CAUSE ANY DELAY IN THE SURGERY. THIS REPORT INVOLVES ONE (1) PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806678 ↗MalfunctionJun 26, 2024Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE SURGERY ON JUNE 4, 2024. THERE WAS A 10 MINUTES SURGICAL DELAY TO GET THE APPROPRIATE CUTTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19620175 ↗MalfunctionMar 21, 2024Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, WHILE USING A PLATE CUTTER IN A NORMAL FASHION, THE DEVICE BROKE. ONE OF THE JAWS SNAPPED OFF. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A DIFFERENT CUTTING TOOL. THIS REPORT INVOLVES ONE PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL. THIS IS REPORT 1 OF 1 FOR (B)(4) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18952338 ↗MalfunctionDec 1, 2023Break; Crack; Break; Crack
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 7, 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE CUTTER IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. ON NOVEMBER 8, 2023, IT WAS CONFIRMED THAT THE CUTTER TIP WAS CRACKED AND BROKEN OFF. BREAKAGE OCCURS IN THE SAME PLACE ONCE A YEAR FOR THREE YEARS. THE HOSPITAL HAS BEEN RE-BOUGHT THREE TIMES AND ALWAYS BREAKS OFF IN THE SAME PLACE. ONE CASE HAS BEEN REPORTED IN (B)(4). THERE WAS NO IMPACT TO THE CUTTER IN QUESTION FROM DROPPING. THE SURGEON CONCERNED IF THERE IS A STRENGTH PROBLEM DUE TO THE BREAKAGE AT THE SAME LOCATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CUTT-PLIERS IN-LINE F/LOCK PL 1.3+VA LOC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18248200 ↗MalfunctionNov 10, 2023Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem
DEVICE REPORT FROM SWEDEN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A PLIERS SHOWED SIGNS OF RUST. THE DEVICE HAD BEEN USED AND STERILIZED ONLY ONCE. THE ISSUE WAS DISCOVERED BY THE STERILITY TECHNICIAN. THIS REPORT IS FOR A PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18113654 ↗MalfunctionMay 25, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW ZEALAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT USING PLATE CUTTERS FROM VA HAND LOAN SET - PLATE CUTTERS SNAPPED WHEN USING - WHILE CUTTING STRUT PLATE. SURGEON DID NOT REPORT USING EXCESSIVE FORCE. THERE WAS NO SURGICAL DELAYED THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES CONCOMITANT DEVICE REPORTED: VA LOCKING STRUT PLATE 2.0 12HO RECTANG (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) (B)(4). THIS IS REPORT 1 OF 1 FOR COMPLAINT CUT-PLIERS IN-LINE F/LOCK PL 1.3+VA LOC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17002518 ↗MalfunctionOct 27, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE VA HAND PLATE CUTTER BROKE. THERE WAS NO DELAY IN SURGERY DUE TO THE EVENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15681262 ↗MalfunctionApr 19, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT USING 03.130.270 CUTTING PLIERS AND PLIERS BROKE. THIS REPORT IS FOR ONE (1) CUTT-PLIERS IN-LINE F/LOCK PL 1.3+VA LOC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14142598 ↗MalfunctionMar 2, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION FOR THE METACARPAL BONE OF THE THUMB WITH THE CUTTING PLIERS. WHEN THE SURGEON WAS CUTTING THE PLATE, THE CUTTING PLIERS BROKE. IT WAS POSSIBLE THAT THE PLATE HOLE WAS NOT FULLY INSERTED INTO THE HOLE IN THE CUTTING PLIERS THAT MAY CAUSED THE BREAKAGE. THE DOCTOR COMMENTED THAT HE GRASPED THE CUTTING PLIERS WITHOUT RESISTANCE, AND HE THOUGHT HE WAS ABLE TO CUT THE PLATE; HOWEVER, THE CUTTING PLIERS WERE BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CUTT-PLIERS IN-LINE F/LOCK PL 1.3+VA LOC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13653289 ↗MalfunctionNov 22, 2021Break; Break
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. DURING THE SURGERY, THE TIP OF THE CUTTER/BENDER BROKE WHEN MANIPULATING THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 2-MINUTES DELAY. THERE WAS NO FRAGMENT GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CUTT-PLIERS IN-LINE F/LOCK PL 1.3+VA LOC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12853731 ↗MalfunctionOct 1, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(64) AS FOLLOWS: IT WAS REPORTED THAT, THE PLATE CUTTER IN QUESTION WAS BROKEN AT THE MOVABLE PART OF THE ROOT PLATE CUTTER. THIS REPORT IS FOR ONE (1) SILICONE INSERT F/INLINE PL CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12565220 ↗MalfunctionSep 23, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY WITH THE PLATE CUTTER IN QUESTION. WHEN THE SURGEON USED THE PLATE CUTTER, IT BROKE DURING USE. THE PATIENT OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL. THIS REPORT IS 1 OF 1 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12519274 ↗MalfunctionSep 14, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY WITH THE PLATE CUTTER IN QUESTION. WHEN THE SURGEON USED THE PLATE CUTTER, IT BROKE DURING USE. THE PATIENT OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12467131 ↗MalfunctionSep 6, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE PLATE CUTTER BROKE WHILE CUTTING A PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) PLATE CUTTER/IN-LINE FOR1.3MM LCKNG/1.5-2.0MM VAL PL THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12430980 ↗MalfunctionMay 26, 2021Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE PLATE CUTTER BROKE IN PROCESS OF CUTTING. THERE WAS A DELAY OF TWO (2) MINUTES AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE: UNKNOWN PLATES: HAND (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11889673 ↗MalfunctionFeb 23, 2021Break; Break
DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN AS FOLLOWS: IT WAS REPORTED THAT DURING THE IN SERVICE, THE CLAMP INSTRUMENT BROKE. THIS COMPLAINT IS FOR ONE (1) PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11365669 ↗MalfunctionFeb 17, 2021Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGERY, WHEN PERFORMING CUTTING PROCEDURE, THE PLIER WAS BROKEN. THERE WAS NO FRAGMENT GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 10 MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNK - PLATES. THIS IS REPORT 1 OF 1 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11339727 ↗
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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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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