NA 351.782Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982193995), received between Oct 11, 2017 and Nov 17, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (12 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT THE LOCKING ARM HAS SNAPPED OFF AND IT NO LONGER LOCKS IN PLACE. THE ISSUE WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572428 ↗
• MalfunctionNov 15, 2023Break; Break

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 27-OCTOBER-2023 THAT THE HOLDING FORCEPS IN QUESTION BROKE. THERE WAS NO ADVERSE PATIENT IMPACT, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141134 ↗
• MalfunctionApr 27, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE FORCEPS IN QUESTION WERE FOUND WITH INSTRUMENT DAMAGE. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823257 ↗
• MalfunctionFeb 24, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS BROKE. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HOLD-FORCEPS F/SYNREAM REAMG ROD Ø2.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440081 ↗
• MalfunctionJun 13, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT THE CLAMP IS BROKEN. THIS REPORT IS FOR ONE (1) HOLD-FORCEPS F/SYNREAM REAMING ROD Ø2.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674489 ↗
• MalfunctionJun 2, 2022Break; Break

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CALIPER SHAFT WAS BROKEN. THIS REPORT IS FOR A HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14576847 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS BROKE DUE TO USAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) HOLDING FORCEPS. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543800 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PRODUCTS FOUND BROKEN AFTER SURGERY AND ARE BEYOND REPAIR. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES EIGHTEEN (18) DEVICES. THIS REPORT IS FOR (1) HOLDING FORCEPS THIS REPORT IS 9 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196524 ↗
• MalfunctionDec 27, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS REPORTED NO CONSEQUENCE TO THE PATIENT. UPON VISUAL INSPECTION OF THE RETURNED DEVICE, IT WAS SEEN THAT ONE OF THE JAWS OF THE HOLDING FORCEPS WAS BROKEN.THIS REPORT IS FOR HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087316 ↗
• MalfunctionMar 3, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT ONE (1) HOLDING FORCEPS WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11406027 ↗
• MalfunctionNov 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE HOLDING FORCEPS BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10809200 ↗
• MalfunctionSep 15, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS (B)(6) SITE, IT WAS OBSERVED THAT A HOLDING FORCEPS WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10535938 ↗
• MalfunctionJan 30, 2018Break; Break

  IT WAS REPORTED THAT WHEN THE SALES CONSULTANT PICKED UP A FIELD INVENTORY REAMER SET ON (B)(6) 2018, THE HOLDING FORCEPS WERE FOUND BROKEN. IT IS NOT KNOWN HOW THE FORCEPS BROKE. THE FORCEPS WERE NOT USED IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7227724 ↗
• MalfunctionOct 11, 2017Break; Break

  IT WAS REPORTED THAT HOLDING FORCEPS ARE BROKEN. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6940887 ↗