NA 347.985Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982193629), received between Jan 18, 2017 and Jun 3, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (11 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022. DURING INSPECTION, THE 2 BROKEN SMALL DEPTH GAUGES AND 2 BROKEN SCREW FORCEPS WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SCREW AND PLATE HOLDING FORCEPS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14596498 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING INSPECTION, THE 2 BROKEN SMALL DEPTH GAUGES AND 2 BROKEN SCREW FORCEPS WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SCREW AND PLATE HOLDING FORCEPS. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14596471 ↗
• MalfunctionMar 2, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399063 ↗
• MalfunctionJan 19, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, A SCREW AND PLATE HOLDING FORCEPS WERE OBSERVED TO BE BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) SCREW AND PLATE HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11193554 ↗
• MalfunctionApr 15, 2020Break; Break

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

  Patient problems: No Patient Involvement

  MAUDE report 9961978 ↗
• MalfunctionFeb 14, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A ROUTINE INCOMING INSPECTION OF LOANER SET, THE SCREW AND PLATE HOLDING FORCEPS WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 01 OF 01 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714098 ↗
• MalfunctionJan 3, 2020Break; Break

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

  Patient problems: No Patient Involvement

  MAUDE report 9548350 ↗
• MalfunctionOct 18, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED FORCEPS BROKE INTRAOPERATIVELY DURING AN UNKNOWN PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT. SURGICAL DELAY IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9210024 ↗
• MalfunctionMay 17, 2019Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF A LOANER SET ON APRIL 15, 2019, THE SCREW AND PLATE HOLDING FORCEPS WAS DISCOVERED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SCREW AND PLATE HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8620278 ↗
• MalfunctionMay 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE. DURING THE PROCEDURE, A CANNULATED HEXAGONAL SCREWDRIVER DOES NOT ENGAGED ON THE SCREW HEAD PROPERLY AND A HOLDING FORCEPS FOR CORTEX SCREWS DOES NOT HOLD ITEMS PROPERLY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TWO (2) MINUTES SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SCREW AND PLATE HOLDING FORCEPS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 8600680 ↗
• MalfunctionApr 27, 2017Break; Break

  IT WAS REPORTED THAT TWO INSTRUMENTS WERE DISCOVERED DAMAGED IN STERILE PROCESSING. THE TIP IS BROKEN OFF ON ONE SIDE OF THE SCREW FORCEPS AND THE TIP IS BENT ON THE 4 MM HEX SCREWDRIVER. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6525610 ↗
• MalfunctionJan 18, 2017Break; Break

  IT IS REPORTED WHILE RESTOCKING A MINI-FRAGMENT SET, IT WAS NOTED ONE OF THE TIPS ON THE SCREW AND PLATE HOLDING FORCEPS IS BROKEN OFF. NO PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6260304 ↗