NA 03.632.017Recalls & reported problems
Synthes GmbH · ROD BENDER WITH SILICONE HANDLES · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034718804), received between Nov 6, 2023 and Aug 19, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Degraded2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025, THE THREE ITEMS WERE FOUND TO BE BROKEN/WORN BEYOND REPAIR DURING POST OP INSPECTION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22839268 ↗MalfunctionNov 6, 2023Break; Degraded; Break; Degraded
DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING CONSIGNMENT INSTRUMENT CHECKING ON OCTOBER 19, 2023, THE FOLLOWING INSTRUMENTS NEEDED REPLACEMENT. ONE RATCHET HANDLE: DOES NOT TURN AS INTENDED, QUITE STICKY AND TIGHT. TWO FRENCH ROD BENDER: STIFF, LOOKED INSIDE WHERE THE NOTCH IS AND SEEMED TO HAVE RUSTED, EVERY ATTEMPT TO BRING BACK MOVEMENT, THERE¿S SOME METAL SHAVING OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A ROD BENDER WITH SILICONE HANDLES. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18077438 ↗MalfunctionNov 6, 2023Break; Degraded; Break; Degraded
DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING CONSIGNMENT INSTRUMENT CHECKING ON OCTOBER 19, 2023, THE FOLLOWING INSTRUMENTS NEEDED REPLACEMENT. -ONE RATCHET HANDLE: DOES NOT TURN AS INTENDED, QUITE STICKY AND TIGHT. -TWO FRENCH ROD BENDER: STIFF, LOOKED INSIDE WHERE THE NOTCH IS AND SEEMED TO HAVE RUSTED, EVERY ATTEMPT TO BRING BACK MOVEMENT, THERE¿S SOME METAL SHAVING OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A ROD BENDER WITH SILICONE HANDLES. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18077331 ↗
Other BENDER devices
- MONARCH 277030000Depuy Spine, LLC · BENDER15 reports
- EXPEDIUM 299704190Medos International Sàrl · BENDER9 reports
- EXPEDIUM 299704200Medos International Sàrl · BENDER9 reports
- EXPEDIUM 299704195Medos International Sàrl · BENDER9 reports
- EXPEDIUM 299704185Medos International Sàrl · BENDER8 reports
- ALTALYNE 5161-04-1700Medos International Sàrl · BENDER8 reports
- NA 03.161.057Synthes GmbH · BENDER5 reports
- EXPEDIUM 279763865Medos International Sàrl · BENDER4 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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