NA 03.211.415Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982076304), received between Nov 30, 2018 and Dec 17, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THEY ARE TAKING OUT THE WIRE AND UPON REMOVAL WIRE SNAPPED OFF. A PATIENT WAS INVOLVED. THEY COULD NOT REMOVE THE WIRE FROM THE PATIENT.

  Patient problems: Foreign Body Reaction

  MAUDE report 23829831 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT WHILE ATTENDING A CLAVICLE CASE, TWO OF THE COMPRESSION WIRES BROKE WHILE BEING USED TO COMPRESS THE PLATE. ONE BROKEN WIRE WAS ABLE TO BE RETRIEVED, BUT THE SECOND ONE WAS NOT AND WAS LEFT IN ONE OF THE SCREW HOLES IN THE PATIENT'S CLAVICLE. ALL REMAINING PIECES OF THE BROKEN WIRES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323068 ↗
• MalfunctionOct 17, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT WHILE ATTENDING A CLAVICLE CASE, TWO OF THE COMPRESSION WIRES BROKE WHILE BEING USED TO COMPRESS THE PLATE. ONE BROKEN WIRE WAS ABLE TO BE RETRIEVED, BUT THE SECOND ONE WAS NOT AND WAS LEFT IN ONE OF THE SCREW HOLES IN THE PATIENT'S CLAVICLE. ALL REMAINING PIECES OF THE BROKEN WIRES WERE DISCARDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23323059 ↗
• MalfunctionJan 7, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT WHILE USING A COMPRESSION WIRE TO AFFIX A CS2 LEFT CLAVICLE SHAFT PLATE, THE THREADED PORTION OF THE WIRE BROKE BELOW THE BEAD AND BECAME ENTRAPPED IN THE BONE. THERE WERE NO SAFETY CONCERNS FROM THE SURGEON FOR THE PATIENT AS THE PIECE IS FULLY ENTRAPPED IN BONE, AND NO ADDITIONAL SURGERY TIME WAS ADDED TO THE CASE. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

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

  MAUDE report 21091154 ↗
• MalfunctionNov 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE COMPRESSION WIRE AND THE VA CLAVICLE 2.7 PLATE FOR THE CLAVICLE DIAPHYSEAL FRACTURE. THE COMPRESSION WIRE IN QUESTION WAS USED FOR TEMPORARY PLATE FIXATION. DURING INSERTION, THE COMPRESSION WIRE IN QUESTION BROKE OFF AT THE BORDER BETWEEN THE BALL AND THE ROOT SIDE OF THE WIRE. THE BREAKAGE OCCURRED WITH THE BALL AND THE TIP INSERTED INTO THE BONE. THE BROKEN WIRE WAS REMOVED WITH RADIO PLIERS. THE SURGERY WAS COMPLETED SUCCESSFULLY. SURGICAL DELAY DUE TO REMOVAL WAS LESS THAN 10 MINUTES. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO BROKEN FRAGMENTS INSIDE THE BODY. PATIENT STATUS: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) COMPR WIRE ø1.6 L150/15. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170581 ↗
• MalfunctionMay 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER TIP IS STRIPPED AND COMPRESSION WIRE IS MISSING THREADS ON THE TIP. NO PATIENT INVOLVEMENT. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1)1.6 COMP WIRE 15 THREAD/150 LENGTH. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17024672 ↗
• MalfunctionApr 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION FOR A CLAVICULAR DIAPHYSEAL FRACTURE WITH THE COMPRESSION WIRE IN QUESTION ON (B)(6) 2023. IN THE SURGERY, THE COMPRESSION WIRE USED FOR TEMPORARY FIXATION WAS BROKEN AT THE TOP OF THE BALL TIP. IT WAS CONFIRMED THAT THE TIP OF THE WIRE DID NOT REMAIN INSIDE THE BODY. ACCORDING TO THE SURGEON, IT MAY HAVE BEEN BROKEN DUE TO EXCESSIVE TENSION DUE TO THE WRONG AXIAL DIRECTION DURING INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED, AND THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691531 ↗
• InjuryDec 3, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE TRYING TO REMOVE THE TEMPORARY COMPRESSION WIRE FROM THE CLAVICLE PLATE IN THE BONE, THE COMPRESSION WIRE BROKE AT THE JUNCTION OF THE BALL AND THE WIRE. THE COMPRESSION WIRE BALL AND THREADED TIP END WAS STILL REMAINING AND HELD DOWN THE PLATE TO THE BONE. THE SURGEON HAD TO USE MULTIPLE INSTRUMENTS TO REMOVE THE REMAINING COMPRESSION WIRE BALL AND THREADED TIP FROM THE PLATE. THE REMAINING COMPRESSION WIRE BALL AND THREADED TIP WERE SUCCESSFULLY REMOVED. REMOVING COMPRESSION WIRE WITH A WIRE DRIVER NEEDED TO USE MULTIPLE INSTRUMENTS TO GRASP THE REMAINING COMPRESSION WIRE BALL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TWENTY (20) MINUTES SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - CABLE/WIRE INSTRUMENTS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK - PLATES: LCP CLAVICLE PLATE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 1.6 COMP WIRE 15 THREAD/150 LENGTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12923987 ↗
• MalfunctionFeb 26, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2021, DURING AN UNKNOWN PROCEDURE, THREE (3) DEPTH GAUGES WERE BROKEN IN THE PROCESS OF MEASURING, THE TIPS WERE COMPLETELY BROKE OFF. A TOTAL OF SEVEN (7) WIRES BROKE OFF THE OLIVE TIPS. ONE (1) CANNULATED SCREWDRIVER WAS BROKEN ALONG WITH TWO (2) STARDRIVE SCREWDRIVER SHAFT T8 WERE STRIPPED. PARALLEL GUIDE AND COUNTERSINK HAD RUST RESIDUE ON THEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH. THIS IS REPORT 3 OF 5 FOR (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388504 ↗
• MalfunctionFeb 26, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THREE (3) DEPTH GAUGES WERE BROKEN IN THE PROCESS OF MEASURING, THE TIPS WERE COMPLETELY BROKE OFF. A TOTAL OF SEVEN (7) WIRES BROKE OFF THE OLIVE TIPS. ONE (1) CANNULATED SCREWDRIVER WAS BROKEN ALONG WITH TWO (2) STARDRIVE SCREWDRIVER SHAFT T8 WERE STRIPPED. PARALLEL GUIDE AND COUNTERSINK HAD RUST RESIDUE ON THEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH. THIS IS REPORT 4 OF 5 FOR (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388448 ↗
• MalfunctionFeb 26, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THREE (3) DEPTH GAUGES WERE BROKEN IN THE PROCESS OF MEASURING, THE TIPS WERE COMPLETELY BROKE OFF. A TOTAL OF SEVEN (7) WIRES BROKE OFF THE OLIVE TIPS. ONE (1) CANNULATED SCREWDRIVER WAS BROKEN ALONG WITH TWO (2) STARDRIVE SCREWDRIVER SHAFT T8 WERE STRIPPED. PARALLEL GUIDE AND COUNTERSINK HAD RUST RESIDUE ON THEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH. THIS IS REPORT 5 OF 5 FOR (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388437 ↗
• MalfunctionFeb 26, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THREE (3) DEPTH GAUGES WERE BROKEN IN THE PROCESS OF MEASURING, THE TIPS WERE COMPLETELY BROKE OFF. A TOTAL OF SEVEN (7) WIRES BROKE OFF THE OLIVE TIPS. ONE (1) CANNULATED SCREWDRIVER WAS BROKEN ALONG WITH TWO (2) STARDRIVE SCREWDRIVER SHAFT T8 WERE STRIPPED. PARALLEL GUIDE AND COUNTERSINK HAD RUST RESIDUE ON THEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH THIS IS REPORT 1 OF 5 FOR (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388413 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THREE DEPTH GAUGES WERE BROKEN IN THE PROCESS OF MEASURING, THE TIPS COMPLETELY BROKE OFF. A TOTAL OF SEVEN WIRES BROKE OFF THE OLIVE TIPS, THE CANNULATED SCREWDRIVER WAS BROKEN, AND TWO T8'S WERE STRIPPED. THE PARALLEL GUIDE AND COUNTERSINK HAD RUST RESIDUE ON THEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 2.0/2.4MM DEPTH GAUGE 50MM (PART NUMBER SD319.006, LOT UNKNOWN, QUANTITY 1). CANNULATED COUNTERSINK FOR 4.5MM CANNULATED SCREWS (PART NUMBER 310.85, LOT UNKNOWN, QUANTITY 1). ADJUSTABLE PARALLEL WIRE GUIDE (PART NUMBER 312.73, LOT UNKNOWN, QUANTITY 1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER (PART NUMBER 314.05, LOT UNKNOWN, QUANTITY 1) STARDRIVE SCREWDRIVER SHAFT T8 105MM (PART NUMBER 314.467, LOT UNKNOWN, QUANTITY 1) 1.25MM PLATE REDUCTION WIRE THRDD TIP W/SM STOP/150MM (PART NUMBER 02.111.500.10, LOT UNKNOWN, QUANTITY 1). 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM (PART NUMBER 02.111.501.10, LOT UNKNOWN, QUANTITY 1). 2.0/2.4MM DEPTH GAUGE 50MM (PART NUMBER SD319.006, LOT UNKNOWN, QUANTITY 2). THIS REPORT INVOLVES ONE (1) 1.6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11379095 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, FOUR (4) HEXAGONAL SCREWDRIVER SHAFTS WERE STRIPPED, ONE (1) ELITE IMPRESSION IMPLANT KIT WAS BROKEN, ONE (1) COMPRESSION WIRE WAS BROKEN, AND THREE (3) NON-THREADED GUIDEWIRE WERE BROKEN. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320045 ↗
• MalfunctionFeb 11, 2021Break; Break

  UPDATED EVENT DESCRIPTION: FOUR (4) TOTAL SHAFTS WERE STRIPPED TO REMOVE A SCREW WHEN THE SURGEON POWERED IN THE SCREW WITHOUT STOPPING SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314074 ↗
• MalfunctionNov 30, 2018Break; Break

  IT WAS REPORTED THAT THE EVENT OCCURRED ON (B)(6) 2018, DURING CHARCOT MIDFOOT FUSION. WHILE APPLYING THE COMPRESSION LAYER, THE SURGEON WENT TOO FAR WHEN USING THE COMPRESSION WIRE AND THE THREAD SNAPPED OFF. ANOTHER WIRE WAS USED TO COMPLETE THE SURGERY. THERE WAS A 2-MINUTE SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8121120 ↗