FMS OMNICUT 283345Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886705022472), received between Sep 6, 2018 and Aug 12, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219578 ↗
• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE OMNICUT 4.2 RES BLADE DEVICE DETACHED FROM THE SHAVER AND FELL OFF WHEN IT WAS REMOVED FROM THE PORTAL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125069 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE OMNICUT 4.2 RES BLADE 5PK WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189729 ↗
• MalfunctionOct 22, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, AFTER OPENING THE OMNICUT 4.2 RES BLADE DEVICE, A WHITE FOREIGN OBJECT WAS FOUND ON THE TIP AND FAT APPEARED TO HAVE SOLIDIFIED. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360544 ↗
• MalfunctionSep 16, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED FROM JAPAN THAT DURING A ROTATOR CUFF REPAIR OF THE SHOULDER JOINT PROCEDURE THE OMNICUT 4.2 RES BLADE DEVICE WHEN THE PRODUCT WAS OPENED, THERE WAS A WHITE COTTON-LIKE SUBSTANCE LODGED IN THE TIP, WHICH WAS CHANGED TO A NEW ONE BEFORE USE. THE PRODUCT WAS NOT USED AND WAS NOT PLACED IN THE BODY. THE NEWLY OPENED ONE COULD BE USED NORMALLY, SO THERE WAS NO PROBLEM. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225198 ↗
• MalfunctionMay 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE WHEN THE SURGEON ATTEMPTED TO ATTACH THE OMNICUT 4.2 RES BLADE 5PK DEVICE TO THE HANDPIECE DEVICE IT DID NOT FIT, NO MATTER HOW MANY TIMES HE TRIED. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273730 ↗
• MalfunctionMay 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT PRIOR TO AN UNKNOWN PROCEDURE AN UNKNOWN SHAVER DEVICE WAS BEING USED WHEN ATTEMPTING TO ATTACH THE TWO (X2) OMNICUT 4.2 RES BLADE SHAVERS IN QUESTION TO THE HANDPIECE; HOWEVER, NEITHER OF THE TWO SHAVERS FIT IN THE HANDPIECE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231832 ↗
• MalfunctionMay 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT PRIOR TO AN UNKNOWN PROCEDURE AN UNKNOWN SHAVER DEVICE WAS BEING USED WHEN ATTEMPTING TO ATTACH THE TWO (X2) OMNICUT 4.2 RES BLADE SHAVERS IN QUESTION TO THE HANDPIECE; HOWEVER, NEITHER OF THE TWO SHAVERS FIT IN THE HANDPIECE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231828 ↗
• MalfunctionApr 18, 2023Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping

  PART DETACHED AND WATER DROPS IN PACKAGE. IT WAS REPORTED BY THE DISTRIBUTOR IN CHINA THAT DURING INCOMING INSPECTION, IT WAS OBSERVED THAT THERE WERE WATER DROPS INSIDE THE UNOPENED PACKAGING OF THE OMNICUT 4.2 (USED W/ MICRO HANDPIECE) DEVICE. IT WAS FURTHER REPORTED THAT THE PLASTIC RING WAS DETACHED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763505 ↗
• MalfunctionJul 11, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN GERMANY THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE OMNICUT 4.2 (USED W/ MICRO HANDPIECE) DEVICE FELL APART WHEN INSERTED INTO THE HANDPIECE AND COULD NOT BE REINSERTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981604 ↗
• MalfunctionJul 11, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN GERMANY THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE OMNICUT 4.2 (USED W/ MICRO HANDPIECE) DEVICE FELL APART WHEN INSERTED INTO THE HANDPIECE AND COULD NOT BE REINSERTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981557 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE METAL DEBRIS WHILE USING THE OMNICUT 4.2 RES BLADE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13931153 ↗
• MalfunctionMar 3, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE METAL DEBRIS WHILE USING THE OMNICUT 4.2 RES BLADE DEVICE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13661128 ↗
• MalfunctionDec 17, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING A ROTATOR CUFF REPAIR SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THERE WERE METAL ABRASIONS WHILE USING THE OMNICUT 4.2 RES BLADE DEVICE. ALL THE BROKEN FRAGMENTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13027788 ↗
• MalfunctionDec 9, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THERE WERE METAL SPREADS IN THE JOINT WHILE USING THE OMNICUT 4.2 RES BLADE DEVICE. ALL THE FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12966725 ↗
• MalfunctionNov 3, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A LUMP OF WHITE HARDENED LUBRICANT WAS ON THE OMNICUT 4.2 RES BLADE DEVICE BEFORE USE ON A PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745434 ↗
• MalfunctionMar 2, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE OMNICUT 4.2 RES BLADE DEVICE WAS NOT ABLE TO GRIND THE BONE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11400231 ↗
• MalfunctionJul 23, 2020Break; Break

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING A SHOULDER REPAIR, METALLIC DEPOSIT WAS RELEASED BY THE OMNICUT 4.2 (USED W/ MICRO HANDPIECE) JUST AFTER ACTIVATING THE BLADE (BEFORE ANY CONTACT WITH THE TISSUE OR THE BONE). FRAGMENTS WERE GENERATED AND PROCEDURE WAS COMPLETED BY CLEANING THE JOINT AND REMOVING THE METAL ON IT WITH A SURGICAL DELAY OF 5 MINUTES. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED ALL FRAGMENTS WERE REMOVED FROM THE PATIENT BUT AN X-RAY WAS NOT DONE TO CONFIRM.

  Patient problems: Not Applicable

  MAUDE report 10317812 ↗
• MalfunctionMay 20, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THE OMNICUT 4.2 RES BLADE 5PK. DURING ABLATION FROM AN OESTEOFYTE THERE WAS METAL ABRASION AT THE DISTAL END. NO SURGICAL DELAY. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10076076 ↗
• MalfunctionNov 19, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE OMNICUT 4.2 RES BLADE 5PK WAS OUTSIDE OF THE BOX. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9342887 ↗
• MalfunctionApr 22, 2019Problem with Sterilization; Tear, Rip or Hole in Device Packaging; Problem with Sterilization; Tear, Rip or Hole in Device Packaging

  DEVICE REPORT FROM MITEK (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE PACKAGING HAD A HOLE IN ONE END AND, THEREFORE, COULD NOT BE USED BECAUSE IT WAS NOT STERILE. THIS WAS FOUND AS THE PRODUCT WAS REMOVED FROM THE BOX OF FIVE (5) BLADES. NO OTHER PRODUCTS IN THE BOX WERE AFFECTED. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE WITH NO PATIENT HARM. THIS WAS SPOTTED PRE-OPERATIVELY AND IT WAS A SHOULDER ARTHROSCOPY CASE. THERE WAS NO DELAY TO THE CASE AS ANOTHER BLADE WAS USED FROM THE BOX. THIS REPORT IS FOR AN OMNICUT 4.2 RES BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8536485 ↗
• MalfunctionFeb 4, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE SURGEON FOUND AN OIL-LIKE FOREIGN MATERIAL WAS ADHERED TO THE INSIDE OF THE BLADE SHAFT OF REPORTED DEVICES DURING THE ARCR SURGERY. THE SURGEON DISCARDED THESE DEVICES. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. IT WAS NOT REPORTED IF THERE WAS A DELAY OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO HARM TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8302199 ↗
• MalfunctionSep 6, 2018Peeled/Delaminated; Peeled/Delaminated

  METALL ABRASION. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES. ADDITIONAL INFORMATION FROM AFFILIATE SEPT 5TH 2018: THE MATERIAL SHAVINGS OCCURRED JUST IN THE BEGINNING OF USING IT, THE FIRST MINUTE. THIS FAILURE DIDN'T RESULT IN SURGICAL DELAY OF GREATER THAN 30 MINUTES OR AN INABILITY TO COMPLETE THE PROCEDURE AS INTENDED. FRAGMENTS WERE RETRIEVED WITH SUCTION OF SHAVER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. ALTERNATIVES WERE READILY AVAILABLE. THERE WERE NO PROCEDURAL OR PATIENT ANATOMY FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. SURGICAL INTERVENTION WAS NOT PLANNED. NO PARTICULATES/SHAVINGS REMAINED IN THE PATIENT. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850919 ↗
• MalfunctionSep 6, 2018Peeled/Delaminated; Peeled/Delaminated

  METALL ABRASION. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES. ADDITIONAL INFORMATION FROM AFFILIATE SEPT 5TH 2018: THE MATERIAL SHAVINGS OCCURRED JUST IN THE BEGINNING OF USING IT. THE FIRST MINUTE. THIS FAILURE DIDN'T RESULT IN SURGICAL DELAY OF GREATER THAN 30 MINUTES OR AN INABILITY TO COMPLETE THE PROCEDURE AS INTENDED. FRAGMENTS WERE RETRIEVED WITH SUCTION OF SHAVER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. ALTERNATIVES WERE READILY AVAILABLE. THERE WERE NO PROCEDURAL OR PATIENT ANATOMY FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. SURGICAL INTERVENTION WAS NOT PLANNED. NO PARTICULATES/SHAVINGS REMAINED IN THE PATIENT. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850917 ↗