NA 398.41Recalls & reported problems
Synthes GmbH · REDUCTION FORCEPS WITH POINTS BROAD-RATCHET · Class 1
Quick summary
This Synthes reduction forceps with points is a surgical instrument used to reposition broken bones. The 35 reports mostly describe the tool breaking, snapping or bending during use, and sometimes leaving it unusable mid-procedure. No deaths or injuries are reported, and in most cases surgery continued or finished normally. There are no recalls naming this device, though reports in the past 12 months (7) are up sharply from the 1 reported in the prior 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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982201386), received between Aug 18, 2014 and Jun 25, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break29
- Material Deformation4
- Device Operates Differently Than Expected1
- Failure To Adhere Or Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient5
- No Patient Involvement3
- Insufficient Information2
- No Code Available1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Break
IT WAS REPORTED THAT TIP OF THE DEVICE IS BROKEN AND IS UNUSABLE. IT DID NOT IMPACT PATIENT CARE, AS THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. THE INSTRUMENT DID NOT BREAK DURING THIS PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25626903 ↗MalfunctionMay 26, 2026Break; Material Deformation
IT WAS REPORTED THAT A VARIETY OF INSTRUMENTS WERE WARPED OR BROKEN. THERE WAS NO REPORTED PATIENT OR USER HARM AND THERE WAS NO DELAY IN SURGERY. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25292516 ↗MalfunctionMay 20, 2026Break; Material Deformation
IT WAS REPORTED SEVERAL INSTRUMENTS WERE NOTED TO BE WARPED OR BROKEN. THE DEVICES HAVE BEEN DISCARDED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25232978 ↗MalfunctionMar 10, 2026Break
IT WAS REPORTED THAT THE FORCEPS TIP WAS BROKEN OFF. THE ELEVATOR WOODEN HANDLE WAS SNAPPED IN HALF. THE SCREWDRIVER TIP WAS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560344 ↗MalfunctionNov 21, 2025Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT OVER THE LAST COUPLE MONTHS, THREE PRODUCTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23623415 ↗MalfunctionJun 9, 2025Break; Break
IT WAS REPORTED THAT THE RATCHET WAS NOT HOLDING TENSION. IT BROKE POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22166629 ↗MalfunctionJul 10, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 THE TINE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS POINTS BROAD-RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19713178 ↗MalfunctionApr 25, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS WERE BROKEN. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 19181257 ↗MalfunctionJan 9, 2024Break; Break
IT WAS REPORTED THAT IN DECEMBER 2023, AFTER VISUAL EXAMINATION, THE DEVICES WERE FOUND TO HAVE THE FOLLOWING CONDITIONS: BENT, BROKEN, AND/OR STRIPPED. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 2 OF 7 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18474133 ↗MalfunctionAug 29, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023 THE DEPTH GAUGE WAS BROKEN AND THE SMALL CLAMP OF REDUCTION FORCEPS WAS BROKEN. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THE PATIENT AND PROCEDURE INVOLVEMENTS WERE UNKNOWN. PATIENT CONSEQUENCES ARE UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS POINTS BROAD-RATCHET. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17642709 ↗MalfunctionAug 17, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED A PAIR OF FORCEPS BROKE POST-OPERATIVELY ON (B)(6) 2023. IT WAS NOTED THE BREAKAGE WAS WITH IN 3 MONTH FROM PURCHASE. THIS REPORT IS FOR ONE REDUCTION FORCEPS WITH POINTS BROAD-RATCHET FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17567955 ↗MalfunctionMar 31, 2023Break; Break
IT WAS REPORTED ON MARCH 1, 2023, THAT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16656128 ↗MalfunctionNov 8, 2022Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE REAMER SHAFT WAS BROKE WHILE ADVANCING DOWN THE CANAL. POINT TO POINTS WILL NOT RETAIN. 1 MINUTE OF SURGICAL DELAY WAS REPORTED. THE REAMER WAS REMOVED AND USED A SMALLER OPTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WAS GENERATED. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS POINTS BROAD-RATCHET. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15756408 ↗MalfunctionSep 5, 2022Material Deformation; Material Deformation
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INSTRUMENT ROOM TECHNICIAN WAS ASSEMBLING THE INSTRUMENT SET AND NOTICED THAT THE TIP OF THE COUPLING SCREW WAS BROKEN OFF. ADDITIONALLY, TWO REDUCTION FORCEPS WERE FOUND WITH THEIR INSPECTING TIPS OUT OF ALIGNMENT AND BENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15355268 ↗MalfunctionSep 5, 2022Material Deformation; Material Deformation
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INSTRUMENT ROOM TECHNICIAN WAS ASSEMBLING THE INSTRUMENT SET AND NOTICED THAT THE TIP OF THE COUPLING SCREW WAS BROKEN OFF. ADDITIONALLY, TWO REDUCTION FORCEPS WERE FOUND WITH THEIR INSPECTING TIPS OUT OF ALIGNMENT AND BENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15355266 ↗MalfunctionOct 7, 2021Break; Break
IT WAS REPORTED THAT, DURING THE STERILE PROCESS THE REDUCTION FORCEPS POINTS BROAD-RATCHET TIP WAS FOUND BROKEN, T15 CANN STRDRV SCRWDRVR SFT SLF-RETAIN WAS STRIPED, & GUIDE BLOCK FOR 2 COLM PL 6 HOLE HEAD/ RT HOLES WERE NOT SMOOTH FOR DROP-IN GUIDE. THE HOLES DO NOT LINE UP WITH THE PLATES ANYMORE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS POINTS BROAD-RATCHET. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12594294 ↗MalfunctionSep 30, 2021Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INSPECTION IT WAS IDENTIFIED THAT THE REDUCTION FORCEPS WITH POINT BROAD-RATCHET POINT TP POINT CLAMP WAS BROKEN. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12555858 ↗MalfunctionAug 20, 2020Break; Break
IT WAS REPORTED ON DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE POINT TO POINT OF A REDUCTION FORCEPS BROKE OFF. THE DOCTOR RETRIEVED THE BROKEN TIP PIECE AND THE TECH DISCARDED IT IN SHARPS CONTAINER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10432585 ↗MalfunctionNov 13, 2019Break; Break
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON A UNKNOWN DATE TWO (2) INSTRUMENTS WERE DAMAGED/BROKEN. THIS REPORT IS FOR ONE (1)REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9317053 ↗MalfunctionFeb 15, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019 DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) HUMERUS, THE REDUCTION FORCEPS WITH POINTS BROAD-RATCHET AND TIP BROKE OFF IN BONE AND WAS RETRIEVED. NOTHING LEFT IN PATIENT. THERE WERE FRAGMENTS GENERATED FROM BROKEN DEVICE. FRAGMENTS WERE REMOVED EASILY WITH NO DELAY. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8343679 ↗MalfunctionJan 3, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE PROXIMAL HUMERUS, SURGEON WAS USING REDUCTION FORCEPS WITH POINTS BROAD-RACHET FROM THE LOCKING COMPRESSION PLATE (LCP) SMALL FRAGMENT TRAY TO MAINTAIN REDUCTION AND PLATE PLACEMENT ON THE HUMERUS. WHILE GRABBING ANOTHER INSTRUMENT, THE SURGEON BUMPED INTO THE FORCEPS CLAMPED ONTO THE PLATE, KNOCKING IT ONTO THE GROUND. AS A RESULT, ONE OF THE TIPS OF THE REDUCTION FORCEPS WITH POINTS BROAD-RACHET BROKE. THE BROKEN FORCEPS WERE REMOVED, EASILY, WITHOUT PATIENT HARM. THE TIP OF FORCEP WAS LOCATED IMMEDIATELY AND THE SURGERY CONTINUED WITH THE USED OF ANOTHER REDUCTION FORCEPS WITH POINTS BROAD-RACHET FROM THE LCP SMALL FRAGMENT TRAY. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8214549 ↗MalfunctionSep 14, 2018Break; Break
IT WAS REPORTED THAN ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE BROAD-RATCHET OF THE REDUCTION FORCEPS WAS LOOSE. PATIENT AND SURGICAL INVOLVEMENT UNKNOWN. WHILE THE DEVICE WAS BEING INVESTIGATED BY THE MANUFACTURER, IT WAS NOTED THE TIP WAS BROKEN. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7878420 ↗MalfunctionAug 24, 2018Break; Break
IT WAS REPORTED THAT DURING A ROUTINE INSPECTION ON (B)(6) 2018, IT WAS FOUND THAT ONE (1) BROAD REDUCTION FORCEPS WON'T HOLD. THERE IS NO PATIENT INVOLVEMENT. THE FORCEPS WAS FOUND TO BE BROKEN DURING INVESTIGATION AT THE MANUFACTURER. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7814007 ↗MalfunctionJul 11, 2018Break; Break
IT WAS REPORTED THAT DURING A ROUTINE PREVENTATIVE MAINTENANCE PROCEDURE, THE FOLLOWING ISSUES WERE IDENTIFIED: FIVE (5) DEPTH GAUGE FOR SMALL SCREWS HAD A BENT NEEDLE; ONE (1) REDUCTION FORCEPS WITH JAW-RATCHET HAD A BROKEN TIP; ONE (1) REDUCTION FORCEPS WITH POINTS BROAD-RATCHET HAD A BROKEN TIP; ONE (1) REDUCTION FORCEPS WITH POINTS BROAD-RATCHET HAD A WEAK GRIP; ONE (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET HAD A BROKEN TIP; ONE (1) REDUCTION FORCEPS WITH POINTS NARROW-RATCHET HAD A WEAK GRIP; ONE (1) APPLICATION INSTRUMENT FOR STERNAL ZIPFIX HAD A BROKEN TIP. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7678491 ↗MalfunctionMay 24, 2018Break; Break
IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2018, THE SURGEON BENT THE POINTED TIPS OF A SET OF REDUCTION FORCEPS WITH POINTS BROAD-RATCHET ON PURPOSE TO ACCOMMODATE WHAT HE NEEDED FOR THE SURGERY, BUT IN THE PROCESS, THE SURGEON BENT THE TIPS TOO MUCH. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE BUT WERE EASILY RETRIEVED. THE SURGEON USED ANOTHER SYNTHES FORCEPS TO FINISH THE SURGERY. THERE WERE NO SURGICAL DELAYS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE PATIENT IN STABLE/GOOD CONDITION. THIS REPORT IS FOR A REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7540822 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.