HOFFMANN 4960-3-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540492791), received between May 7, 2021 and May 29, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Positioning Failure” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "WE RECEIVED A COMPLAINT ABOUT THE HOFFMANN2 MICRO LENGTHENER VIA SURGEON/NURSES AT THE (B)(6). THE CASE HAPPENED ON (B)(6) 2024 FOR A METACARPAL LENGTHENING CASE. THE SURGEON REPORTED THAT THE DISTRACTOR DIDN'T WORK AS EXPECTED. AS THE MICRO-LENGTHENER WAS USED TO DISTRACT THE BONE, THE PINS MOVED INSIDE THE CLAMP AND RESULTED IN AN UNEXPECTED OUTCOME." THE PATIENT HAD TO COME BACK AN ADDITIONAL THREE TIMES TO HAVE THE DEVICE ADJUSTED ((B)(4) VISITS IN TOTAL). THE FIRST 4 I BELIEVE WOULD HAVE BEEN UNDER ANAESTHETIC 2 GENERAL AND 2 LOCAL AS THERE WAS PINS BEING INSERTED AND SIGNIFICANT ADJUSTMENT BEING MADE. THE FINAL TIME THEY WERE NOT UNDER ANAESTHETIC AS JUST PINS WERE BEING REMOVED. THE REVISIONS TOOK PLACE BECAUSE THE PINS WOULD BECOME LOSE WITHIN THE CLAMP AND THUS BE INEFFECTIVE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19413675 ↗
• InjuryMay 29, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "WE RECEIVED A COMPLAINT ABOUT THE HOFFMANN2 MICRO LENGTHENER VIA SURGEON/NURSES AT THE MCINDO CENTRE. THE CASE HAPPENED ON (B)(6) 2024 FOR A METACARPAL LENGTHENING CASE. THE SURGEON REPORTED THAT THE DISTRACTOR DIDN'T WORK AS EXPECTED. AS THE MICRO-LENGTHENER WAS USED TO DISTRACT THE BONE, THE PINS MOVED INSIDE THE CLAMP AND RESULTED IN AN UNEXPECTED OUTCOME." THE PATIENT HAD TO COME BACK AN ADDITIONAL THREE TIMES TO HAVE THE DEVICE ADJUSTED (5 VISITS IN TOTAL). THE FIRST 4 I BELIEVE WOULD HAVE BEEN UNDER ANAESTHETIC 2 GENERAL AND 2 LOCAL AS THERE WAS PINS BEING INSERTED AND SIGNIFICANT ADJUSTMENT BEING MADE. THE FINAL TIME THEY WERE NOT UNDER ANAESTHETIC AS JUST PINS WERE BEING REMOVED. THE REVISIONS TOOK PLACE BECAUSE THE PINS WOULD BECOME LOSE WITHIN THE CLAMP AND THUS BE INEFFECTIVE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19413671 ↗
• InjuryMay 27, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "WE RECEIVED A COMPLAINT ABOUT THE HOFFMANN2 MICRO LENGTHENER VIA SURGEON/NURSES AT THE MCINDO CENTRE. THE CASE HAPPENED ON (B)(6) 2024 FOR A METACARPAL LENGTHENING CASE. THE SURGEON REPORTED THAT THE DISTRACTOR DIDN'T WORK AS EXPECTED. AS THE MICRO-LENGTHENER WAS USED TO DISTRACT THE BONE, THE PINS MOVED INSIDE THE CLAMP AND RESULTED IN AN UNEXPECTED OUTCOME."(B)(6) 2024 - ADDITIONAL INFORMATION. INSTEAD THE PATIENT HAD TO COME BACK AN ADDITIONAL THREE TIMES TO HAVE THE DEVICE ADJUSTED ((B)(6) VISITS IN TOTAL). THE FIRST 4 I BELIEVE WOULD HAVE BEEN UNDER ANAESTHETIC 2 GENERAL AND 2 LOCAL AS THERE WAS PINS BEING INSERTED AND SIGNIFICANT ADJUSTMENT BEING MADE. THE FINAL TIME THEY WERE NOT UNDER ANAESTHETIC AS JUST PINS WERE BEING REMOVED. THE REVISIONS TOOK PLACE BECAUSE THE PINS WOULD BECOME LOSE WITHIN THE CLAMP AND THUS BE INEFFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400630 ↗
• InjuryMar 26, 2024Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  AS REPORTED: "PATIENT TRIED TO DO DAILY TIGHTENING OF MINI RAIL AND NOTICED THAT THE MACHINE WAS NOT ENGAGING. WITHIN HOURS OF THIS DISCOVERY, HER FOOT BECAME EXTREMELY SWOLLEN AND SHE WAS ADMITTED TO THE HOSPITAL. HARDWARE WAS SWITCHED OUT IN HER ROOM, BUT THE PHYSICIAN IS NOT SURE IF THEY WILL NEED TO REVISE YET OR NOT. WE ARE AWAITING FURTHER IMAGING."

  Patient problems: Swelling/ Edema

  MAUDE report 18981707 ↗
• InjuryAug 10, 2021Migration; Migration

  IT WAS REPORTED THE HOFFMANN MICRO LENGTHENER ASSEMBLY IMPLANTED / INSTALLED ON (B)(6)2021 FOR 4TH METATARSAL OSTEOTOMY & LENGTHENING. SURGEON REPORTED THIS WEEK THAT DISTAL CLAMP ON MONOTUBE FIXATOR HAD BECOME LOOSE, AND WAS CAUSING A SHIFT INTO PLANTAR FLEXION OF THE PATIENT'S 4TH METATARSAL. TO DATE, NOTHING UNCORRECTABLE HAS OCCURRED PER DISCUSSION WITH THE SURGEON AND PATIENT. PATIENT WAS DIRECTED TO STOP AT-HOME LENGTHENING PROCEDURES UNTIL THE EXCHANGE COULD BE MADE, AND TO MY UNDERSTANDING, HAS BEEN DIRECTED TO RESUME AS OF THE INSTALLATION OF NEW DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 12304847 ↗
• InjuryMay 7, 2021Material Integrity Problem; Material Integrity Problem

  AS REPORTED: "THE EXTERNAL FIXATOR OF THE PATIENT OPERATED ON JANUARY 28 WAS DAMAGED ON APRIL 12. FOR REPLACEMENT WORK BY URGENT ARRANGEMENT ON THE DAY."

  Patient problems: Insufficient Information

  MAUDE report 11791033 ↗