NA 03.111.907Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982072658), received between Oct 22, 2019 and Aug 11, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K113364); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216497 ↗
• MalfunctionDec 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE DOCTOR NOTICED THE ITEM WAS BENT AS THE SETS WERE BEING OPENED BEFORE THE CASE. WE DID NOT USE THE ITEM BEFORE IT WAS NOTICED BY THE DOCTOR. WE WERE NOT ABLE TO GET A REPLACEMENT FOR THE CASE SO IT WAS MUCH MORE DIFFICULT THAN USUAL TO REALIGN AFTER THE OSTEOTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906205 ↗
• MalfunctionDec 11, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THE DISTRACTION INSTRUMENT IS MISSING A SCREW. THE ITEM IS MISALIGNED. ADDITIONALLY, THE DEPTH GAUGE HAS ISSUES WITH MEASURING THE CORRECT SCREW LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782820 ↗
• MalfunctionMar 14, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN ULNAR OSTEOTOMY COMPRESSION/DISTRACTION INSTRUMENT. THE INSTRUMENT WAS NOTICED BROKEN DURING RESET OF A TRAY POSTOPERATIVELY. THE DIAL TO APPLY COMPRESSION IS STUCK AND DOESN'T TURN ANYMORE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS BROKEN INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605894 ↗
• MalfunctionJan 24, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025 DURING THE PROCEDURE, WHILE FOLLOWING THE SURGICAL TECHNIQUE OF INSERTING THE 2.0MM WIRES INTO THE COMPRESSION/DISTRACTION INSTRUMENT, THE SURGEON EXPERIENCED EXTREME DIFFICULTY INSERTING THE WIRES. THE WIRES WERE NEW, UNUSED, AND WERE NOT BENT. IN ADDITION, THE SURGEON EXPERIENCED EXTREME DIFFICULTY TURNING THE SPINDLE ON THE COMPRESSION/DISTRACTION DEVICE. UPON FURTHER INSPECTION OF THE INSTRUMENT, IT SEEMS THAT THE INSTRUMENT IS SLIGHTLY BENT, CREATING AN IMBALANCE IN BOTH THE WIRE HOLES ALONG WITH THE SPINDLE MECHANISM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAYS, NO PATIENT CONSEQUENCES AND NO OTHER MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228239 ↗
• MalfunctionSep 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT 2.0MM DRILL TIP WIRE BECAME STUCK IN CANNULATION OF COMPRESSION/DISTRACTION DEVICE. SURGEON WAS ABLE TO REMOVE THE WIRE WITH PLIERS BUT CANNULATION WAS UNUSABLE. CASE CONTINUED WITH ONLY USING WIRES IN 3 REMAINING HOLES OF COMPRESSION/DISTRACTION DEVICE. ON INSPECTION AFTER THE CASE THE WIRES IN THE SET ALL LOOKED HEAVILY USED AND BLUNT/BENT SO WERE DISCARDED. ULNA SHORTENING OSTEOTOMY. SURGERY WAS DELAYED FOR 5 MINUTES AND MORE. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. THIS REPORT IS FOR ONE (1) COMP/DISTRACTION INSTR FOR ULNA OSTEO. THIS IS REPORT 1 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491304 ↗
• MalfunctionMay 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSPECTION OF BACK UP INSTRUMENTS ON AN UNKNOWN DATE, THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HAD A LOOSE NEEDLE, TWO HANDLE WITH MINI QUICK COUPLING HAD ISSUES LOCKING DRIVER SHAFT, TWO HOLD-SL Ø2 F/COMPRESSION/DISTRACTION DEV DID NOT LOCK WIRES, COMPRESSION/DISTRACTION INSTRUMENT TURN KNOB KEPT POPPING OFF, COMP/DISTRACTION INSTR FOR ULNA OSTEO HAD A WIRE STUCK INSIDE THE DEVICE, AND A T-HANDLE WITH QUICK COUPLING HAD A CONICAL EXTRACTION SCREW STUCK INSIDE. THERE WAS NO HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A COMPRESSION/DISTRACTION INSTR FOR ULNA OSTEOTOMY SYSTEM. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14289048 ↗
• MalfunctionDec 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  UPDATED CONCOMITANT DEVICE REPORTED: KWIRE (PART 02.111.903, LOT 4L12699, QUANTITY 1).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928161 ↗
• MalfunctionNov 25, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT IN THE COMPRESSION-DISTRACTOR INSTRUMENT, THE 2.0 KIRSCHER WIRES WOULD NOT PASS THROUGH THE INNER PORTION OF THE PATELLAE. ADDITIONALLY, THE PIVOT KNOB DID NOT ROTATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICES: UNK - KNOB (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) UNK - GUIDE/COMPRESSION/K-WIRES (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE COMPRESSION/DISTRACTION INSTR FOR ULNA OSTEOTOMY SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10899450 ↗
• MalfunctionJan 3, 2020Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ULNAR SHORTENING PROCEDURE ON (B)(6) 2019, THE UNKNOWN K-WIRE GOT STUCK IN THE COMPRESSION/DISTRACTION INSTRUMENT. THE SURGEON HAD TO USE A PLIERS TO PULL THE WIRE OUT. THE GUIDE WAS USED AGAIN, BUT THE SURGEON COULD NOT ABLE TO PUT THE WIRE THROUGH THE HOLE WHERE THE WIRE HAD STUCK BEFORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SLIGHT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9549200 ↗
• MalfunctionOct 22, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE COMPRESSION/DISTRACTION INSTRUMENT WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) COMPRESSION/DISTRACTION INSTR FOR ULNA OSTEOTOMY SYSTEM. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9217667 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113364. One submission often covers many models, so check the product and lot details in each record.

• Z-1274-2014 · Jan 7, 2014 · Terminated
  Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bon