Dermatome 88710100Recalls & reported problems

Summary

The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 00889024464834), received between Apr 22, 2021 and Sep 23, 2026 — classified as 23 injuries, 219 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (97 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 25 most recent of 242 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Malposition of Device; Calibration Problem; Material Deformation; Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872921 ↗
• MalfunctionSep 8, 2026Calibration Problem

  It was reported that outside of surgery issue identified during Recall HHE-2025-00141. The issue is related to receiving multiple complaints where the devices were cutting beyond the proper depth due to a misaligned thickness control bar. Proactively carry out maintenance and repair. There was no patient involvement. Upon evaluation it was identified that the widthplate was damaged. Due diligence is complete Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50666706 ↗
• MalfunctionAug 18, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307487 ↗
• MalfunctionAug 13, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50234380 ↗
• MalfunctionApr 16, 2026Component Missing

  IT WAS REPORTED THAT DURING MAINTENANCE THE DEVICE HAD 4 WORN SCREWS, WORN RECIPROCATION ARM, THE CONTROL BAR IS MISSING, THE BALL HAS FALLEN OUT OF THE BALL SCREW OF THE ADJUSTMENT ARM AND THE SCREW CANNOT BE UNSCREWED FROM INSIDE. THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE MOTOR SPEEDS WERE UNSTABLE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899889 ↗
• MalfunctionApr 15, 2026Failure to Cut

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE BLACK PIN IN THE MIDDLE OF THE HANDPIECE WAS NOT WORKING PROPERLY, AND THE HANDPIECE WAS CUTTING TOO THICK AND MAY NEED TO BE RECALIBRATED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887477 ↗
• MalfunctionApr 14, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, IT WAS FOUND THAT THE DEVICE WAS IN NEED OF REPAIR. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE MOTOR SPEEDS WERE UNSTABLE AND WIDTH PLATES WERE DAMAGED. THERE WAS NO NOTE OF PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877074 ↗
• MalfunctionApr 14, 2026Power Problem

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT HAD LACK OF POWER TO DRIVE THE BLADES. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE UNIT HAD INCONSISTENT MOTOR SPEED. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875067 ↗
• MalfunctionApr 13, 2026Pressure Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE DEVICE DOES NOT APPLY PRESSURE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE MOTOR WAS SEIZED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24865107 ↗
• MalfunctionMar 30, 2026Intermittent Loss of Power

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT HAD A RECIPROCATING ARM INTERMITTENT STOP. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728636 ↗
• InjuryMar 3, 2026Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, THE ZIMMER DERMATOME WAS MALFUNCTIONING - TWO SEPARATE MACHINES WERE OPENED AND BOTH WERE MALFUNCTIONING. THIS WAS NOT APPARENT AT FIRST - BUT WHEN THE FIRST MACHINE WAS USED TO HARVEST SKIN, IT WAS CLEAR THAT IT WAS NOT SMOOTHLY TAKING SKIN, AND IN FACT, IT MADE A FULL THICKNESS INJURY TO THE SKIN WITH A LACERATION ALL THE WAY THROUGH DERMIS AT THE START OF THE GRAFT HARVEST. THEREFORE SKIN GRAFT HARVEST WAS IMMEDIATELY ABANDONED. AS SUCH, THE WOUND WAS COVERED WITH BTM CUT TO SIZE AND SEWN IN PLACE WITH 4-0 MONOCRYL. AN ADDITIONAL SURGERY WAS REQUIRED BUT WAS NOT COMPLETED AT THIS INSTITUTION. THERE WAS PATIENT INJURY, AND AN UNKNOWN DELAY. THE TAKEN GRAFT WAS DAMAGED AND BECAME UNUSABLE. AFTER THE SECOND MACHINE SOUNDED LIKE THE FIRST THE ADDITIONAL GRAFT ELEMENT WAS ABANDONED ENTIRELY. DUE DILIGENCE IS COMPLETED AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 24497581 ↗
• MalfunctionMar 2, 2026Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS NOT CATCHING THE SKIN WHEN ATTEMPTING TO PERFORM A GRAFT. IT IS UNKNOWN IF THERE WAS DELAY BUT IT WAS NOTED THERE WAS PATIENT IMPACT. HOWEVER, DETAILS WERE NOT PROVIDED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24482462 ↗
• MalfunctionMar 2, 2026Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS NOT CATCHING THE SKIN WHEN ATTEMPTING TO PERFORM A GRAFT. IT IS UNKNOWN IF THERE WAS DELAY BUT IT WAS NOTED THERE WAS PATIENT IMPACT. HOWEVER, DETAILS WERE NOT PROVIDED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24482191 ↗
• MalfunctionFeb 24, 2026Material Deformation; Naturally Worn

  No additional event information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428407 ↗
• MalfunctionFeb 18, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE BLADE ADJUSTMENT LEVER IS LOOSE. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24381149 ↗
• MalfunctionFeb 16, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE UNIT WAS SENT IN FOR PREVENTATIVE MAINTENANCE AND NEEDED CORRECTIVE REPAIR. THERE WAS NO ALLEGED MALFUNCTION AGAINST THE DEVICE WHEN IT WAS RECEIVED INITIALLY. THERE WAS NO PATIENT INVOLVEMENT. DURING INVESTIGATION IT WAS FOUND THAT THE LEVER WAS LOOSE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24346508 ↗
• MalfunctionFeb 6, 2026Failure to Power Up

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT DOESN'T WORK, IT DOES NOT POWER ON. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT THE MOTOR SPEEDS WERE NOT STABLE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278546 ↗
• MalfunctionJan 21, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT OUTSIDE OF SURGERY ON AN UNKNOWN TIME, THE DEVICE WAS SENT TO PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. AFTER INVESTIGATION AN INCONSISTENT SPEED WAS FOUND. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141571 ↗
• MalfunctionJan 12, 2026Mechanical Problem

  IT WAS REPORTED THAT THE HANDPIECE STOPPED WORKING OUTSIDE OF SURGERY. THERE WAS NO PATIENT INVOLVEMENT. AT DEVICE EVALUATION IT WAS NOTED THAT THE UNIT HAD MOTOR SPEEDS THAT WERE OUT OF SPECIFICATION ON THE LOW END. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24043509 ↗
• MalfunctionDec 31, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE LEFT A TEAR ON THE GRAFT. THERE WAS NO PATIENT IMPACT BUT IT IS UNKNOWN IF THERE WAS DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934120 ↗
• MalfunctionDec 31, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE LEFT A TEAR ON THE GRAFT. THERE WAS NO PATIENT IMPACT BUT IT IS UNKNOWN IF THERE WAS A DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933980 ↗
• MalfunctionDec 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, ON AN UNKNOWN DATE, THE UNIT HAD AN UNKNOWN ISSUE. DAMAGED WIDTH PLATE WAS CONFIRMED. IT IS UNKNOWN IF A PATIENT WAS IMPACTED OR IF A DELAY OCCURRED. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23850477 ↗
• MalfunctionDec 18, 2025Intermittent Loss of Power; Intermittent Loss of Power

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 23843786 ↗
• MalfunctionDec 16, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CUSTOMER RETURNED THE LOANER. THERE WAS NO ALLEGED DEFICIENCY WHEN DEVICE WAS RETURNED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. DURING DEVICE EVALUATION, THE DEVICE WAS LEAKING AIR AND HAD DAMAGED WIDTH PLATE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822154 ↗
• MalfunctionDec 15, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING SURGERY, THE MOTOR WAS SLOWING DOWN. THERE WAS NO PATIENT IMPACT. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809933 ↗