NA 03.100.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982070852), received between Sep 17, 2021 and Aug 10, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191281 ↗
• MalfunctionAug 4, 2026Break

  It was reported that when molding the template to determine the required plate length, it fractured. The specialist was not bothered, and the procedure was not delayed, as the surgery was successfully completed using another template.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130588 ↗
• MalfunctionSep 19, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE DOCTOR BROKE THE INSOLE IN QUESTION WHILE USING IT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A BENDING TEMPLATE FOR 3.5MM LP CRVD RECON PL-88MM RAD/16H. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447048 ↗
• MalfunctionApr 29, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN COLOMBIA THAT DURING AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE MOMENT THE SPECIALIST MANEUVERS THE TEMPLATE DEVICE TO MOLD IT ONTO THE PATIENT'S BONE, IT EASILY SPLIT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) BEND-TEMPL F/LOWPROFILE3.5 RECOPL-CURVED DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250284 ↗
• MalfunctionApr 13, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2022, IT WAS REPORTED THAT THE SPECIALIST MANEUVERED THE TEMPLATE TO MOLD IT, BUT IT WAS FINISHED BROKEN. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) BEND-TEMPL F/LOWPROFILE3.5 RECOPL-CURVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14105263 ↗
• MalfunctionSep 17, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE DRILL BIT LOSES ITS EDGE AFTER SEVERAL USES AND DOES NOT DRILL ANY MORE. AT THE TIME THAT THE SPECIALIST PERFORMED MANEUVERS TO SHAPE THE TEMPLATE WITH THE PATIENT'S BONE, IT BROKE WITHOUT USING ANY FORCE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) BENDING TEMPLATE FOR 3.5MM LP CRVD RECON PL-88MM RAD/16H. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490904 ↗