FOREFOOT SOLUTIONS™ 119105NDRecalls & reported problems
Newdeal · The Scarf clamp is used in Scarf osteotomy, where its specific design (asymmetrical jaws) allows variable lateral displacement and bone fragments holding in the correct position prior to screw fixation. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780051862), received between May 31, 2022 and Jun 5, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2022Break; Break
IT WAS REPORTED THAT, DURING SURGERY, THE BOLD CLAMP BROKE. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO OTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14599418 ↗MalfunctionMay 31, 2022Break; Break
IT WAS REPORTED THAT, DURING A SCARF PROCEDURE, TWO (2) BOLD CLAMP WERE BROKEN WHILE OUTSIDE OF THE PATIENT (AND NO PIECES FELL IN). SURGERY WAS RESUMED, WITH A DELAY OF FEWER THAN 30 MINUTES. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. THE PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14545591 ↗
Other CLAMP devices
- ATTUNE 2544-00-001Depuy (Ireland) · CLAMP144 reports
- NA 2178-63-134Depuy (Ireland) · CLAMP137 reports
- ATTUNE 2545-01-055Depuy (Ireland) · CLAMP128 reports
- SPECIALIST 86-5035Depuy (Ireland) · CLAMP101 reports
- SPECIALIST 96-6670Depuy Orthopaedics, Inc. · CLAMP92 reports
- ATRAUMATA FB469RAesculap AG · CLAMP1 recall0 reports
- Centurion I68080Centurion Medical Products Corporation · CLAMP1 recall0 reports
- ATRAUMATA FB459RAesculap AG · CLAMP1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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