NA 324.033Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982190994), received between Jan 3, 2017 and Jul 11, 2023 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023Break; Entrapment of Device; Break; Entrapment of Device

  THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298835 ↗
• InjuryJul 11, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, TWO DEVICES BROKE. PATIENT WAS BEING TREATED FOR A FRACTURE OF THE LEFT DISTAL FEMUR WITH A LOCKING COMPRESSION PLATE (LCP). DURING PLACEMENT OF THE FEMUR PLATE, AN ANCILLARY DRILL BIT BROKE IN THE BONE AND COULD NOT BE REMOVED. THIS REPORT IS FOR A PULL REDUCTION INSTRUMENT FOR LISS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17298686 ↗
• InjuryMay 19, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A REDUCTION INSTRUMENT BROKE IN THE PATIENT INTRAOPERATIVELY ON AN UNKNOWN DATE. THE SURGEON HAD TO RE-OPEN THE PATIENT IN ORDER TO RETRIEVE THE BROKEN PART. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A REDUCTION INSTRUMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14435431 ↗
• MalfunctionFeb 2, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE BROCADED TIP WAS SPLIT WHICH WAS REMOVED AND THE TIP STAYS INSIDE THE PATIENT'S BONE. THIS REPORT IS FOR ONE (1) PULLING DEVICE Ø4 L240 F/LISS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13429596 ↗
• MalfunctionApr 15, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING DISTAL FEMORAL FRACTURE, SURGEON USED PULLING DEVICE TO PULL BONE TOWARDS THE PLATE AND THEN INSERTED LOCKING SCREWS. THE PULLING DEVICE WAS DISCOVERED TO BE BROKEN ONCE REMOVED WITH DISTAL TIP REMAINING IN SITU. THE DISTAL TIP WAS REMOVED BY ADDITIONAL INCISION AND WITH THE HELP OF INTRA-OPERATIVE X-RAYS. X-RAY IMAGES CONFIRMED NO REMNANTS. THERE WAS SURGICAL DELAY OF TWENTY (20) MINUTES DUE TO REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) PULL REDUCTION INSTRUMENT FOR LISS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672154 ↗
• MalfunctionJun 24, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING DECONTAMINATION, THE PULLING DEVICE WAS FOUND BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8727828 ↗
• MalfunctionJun 12, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE, A PULLING DEVICE WAS NOTICED TO HAVE UNKNOWN DAMAGE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT. UPON MANUFACTURER RECEIPT AND INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN. THIS REPORT IS FOR A PULL REDUCTION INSTRUMENT FOR LISS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8691721 ↗
• MalfunctionOct 1, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING DECONTAMINATION THE DEVICE WAS FOUND BROKEN. THIS REPORT IS FOR ONE (1) PULL REDUCTION INSTRUMENT FOR LISS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7924541 ↗
• InjuryJul 13, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE PULL REDUCTION INSTRUMENT FOR LESS INVASIVE STABILIZATION SYSTEM (LISS) BROKE. THE BROKEN FRAGMENT HAS BEEN PARTIALLY LEFT IN SITU. SURGERY WAS COMPLETED WITH NO DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7687076 ↗
• MalfunctionFeb 16, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING CLEANING AND DECONTAMINATION THE DEVICE WAS FOUND BROKEN. NO PATIENT INVOLVEMENT. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7277867 ↗
• InjuryAug 31, 2017Break; Material Fragmentation; Break; Material Fragmentation

  FURTHER IT WAS REPORTED THAT THE PATIENT WAS TREATED ON (B)(6) 2017 FOR THE SUPRA-INTERCONDYLAR FRACTURE OF THE LEFT FEMUR AND WAS IMPLANTED WITH 9-HOLE LOCKING COMPRESSION PLATE (LCP) DISTAL FEMUR PLATE AND SCREWS. PER SURGEON NO FURTHER INTERVENTION IS PLANNED AT THIS TIME. THE PLATE AND SCREWS MAY BE REMOVED ONE DAY, BUT THE BROKEN FRAGMENT WILL NOT BE REMOVED BECAUSE IT IS TOO BURIED IN THE BONE UNLESS THERE SHOULD BE A PSEUDARTHROSIS AND THE NEED TO PERFORM BONE AUGMENTATION OR BONE TRIMMING SUCH AS IT WOULD NOT BE APPROPRIATE TO REMOVE THIS FRAGMENT. THE PATIENT IS YOUNG, DURING THE PROCEDURE, THE BONE COULD BE CONSIDERED VERY RESISTANT AND OF EXCELLENT QUALITY AND THE PATIENT IS OF A VERY MUSCULAR MORPHOTYPE. THE PATIENT IS FINE.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6834020 ↗
• InjuryMar 5, 2017Break; Material Fragmentation; Break; Material Fragmentation

  CUSTOMER QUALITY UNIT RECEIVED A MAUDE REPORT FORWARDED FROM DEPARTMENT OF HUMAN SERVICES; THIS REPORT IS AGAINST USER FACILITY REPORT# (B)(4). ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6379571 ↗
• InjuryJan 24, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A DEVICE BROKE DURING A PROCEDURE AND PART OF IT WAS LEFT IN THE PATIENT. THE PATIENT OUTCOME WAS REPORTED AS GOOD. A PROLONGATION WAS REPORTED BUT UNKNOWN HOW MANY MINUTES. IT WAS NOTED THAT THE ENTIRE BROKEN PIECE WAS EVENTUALLY REMOVED; HOWEVER IT IS UNKNOWN IF IT WAS REMOVED DURING THE SAME PROCEDURE OR IF A NEW PROCEDURE HAD TO BE COMPLETED TO REMOVE THE DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6273997 ↗
• MalfunctionJan 3, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PULLING DEVICE WAS FOUND BROKEN AT THE LOAN DEPARTMENT. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE PART. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6218243 ↗