N/A (REF 375-544-000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00885825014247), received between Nov 30, 2016 and Aug 29, 2022 — classified as 18 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Break” (86 reports).

8 other recalls cover devices cleared under the same FDA submission (K012635); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2022Break; Break

  IT WAS REPORTED THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND EXTENDED PROCEDURE TIME WAS 5 MINUTES TO RETRIEVE THE TIP WITH GRASPERS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312502 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THE TIP BROKE OFF DURING SURGERY. THE TIP BROKE AS SOON AS THE SHAVER WAS TURNED ON AND FELL WITHIN THE PATIENT AND WAS RETRIEVED VIA A RTHROSCOPIC GRASPER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 10 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656573 ↗
• MalfunctionSep 16, 2021Break; Break

  IT WAS REPORTED ITEM 375-544-000 SEIZED UP DURING THE CASE. THE BLADE WOULD NOT ROTATE, EVEN WHEN REMOVED FROM THE HANDPIECE. REPLACE WITH OEM. THE DEVICE FROZE BEFORE THE TIP BROKE. THE USER TRIED TO FORCE IT TO TURN AND THAT'S WHEN THE TIP BROKE OFF. THE DEVICE WAS NOT IN THE PATIENT WHEN IT HAPPENED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485529 ↗
• MalfunctionSep 16, 2021Break; Break

  IT WAS REPORTED THE DISTAL ~5MM OF THE ROTATING INNER BLADE BROKE OFF WHILE IN USE. THE SHAVER BROKE OFF INSIDE THE SHOULDER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS ABOUT 5 MINUTES TO RETRIEVE THE BROKEN PIECE WITH A GRASPER. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485339 ↗
• MalfunctionAug 13, 2021Break; Break

  IT WAS REPORTED THE SERRATED TIP OF THE SHAVER CAME OFF INTO THE PATIENT. IT WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317148 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED THAT AN ARTHROSCOPIC SHAVER BLADE BROKE OFF IN THE PATIENT. THE BROKEN TIP WAS RETRIEVED WITH A GRASPER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME WAS 10 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744926 ↗
• InjuryApr 29, 2021Break; Break

  IT WAS REPORTED THAT THE 8MM TIP OF THE ARTHROSCOPIC SHAVER BROKE OFF DURING SURGERY. X-RAY WAS USED AND THE DEVICE FRAGMENT WAS LOCATED. HOWEVER, THE DEVICE FRAGMENT WAS UNABLE TO BE LOCATED ARTHROSCOPICALLY, SO THE INCISION HAD TO BE WIDENED. THE DEVICE FRAGMENT WAS EVENTUALLY ABLE TO LOCATED WITH C-ARM AND SCOPE. THE TIP HAD EMBEDDED INTO CARTILAGE AND WAS RETRIEVED IN ITS ENTIRETY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744807 ↗
• InjuryApr 27, 2021Break; Break

  IT WAS REPORTED THAT A FOREIGN BODY BROKE OFF FROM THE ARTHROSCOPIC SHAVER DURING A CASE AND WAS POTENTIALLY RETAINED WITHIN THE PATIENT. X-RAY WAS USED TO SEARCH FOR THE FOREIGN BODY. THE FOREIGN BODY WAS NOT RECOVERED. THE COMPLAINANT IS NOT AWARE OF PATIENT HARM AND THE EXTENDED PROCEDURE TIME WAS APPROXIMATELY 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731873 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT THE ARTHROSCOPIC SHAVER BURR BROKE INSIDE THE PATIENT. IT WAS CONFIRMED THAT ALL PIECES WERE REMOVED. NO X-RAY WAS USED TO LOCATE THE BROKEN PIECES AND NO LARGER INCISION WAS MADE TO RETRIEVE THE BROKEN PIECES. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365510 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED THAT THE INNER CUTTING TIP OF THE ARTHROSCOPIC SHAVER BROKE OFF DURING PROCEDURE AND WAS RETRIEVED FROM THE PATIENT BY THE SURGEON. THE BROKEN PIECE WAS RETRIEVED WITH A GRASPER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11083548 ↗
• MalfunctionNov 5, 2020Break; Break

  IT WAS REPORTED THE TIP OF THE ARTHROSCOPIC SHAVER BROKE INSIDE THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. HOWEVER, THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10796417 ↗
• InjuryNov 2, 2020Break; Break

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A KNEE ARTHROSCOPY AND USING THE ARTHROSCOPIC SHAVER. WHILE USING THE ARTHROSCOPIC SHAVER, THE TIP BROKE OFF IN THE PATIENT'S KNEE. THE PHYSICIAN IRRIGATED THE KNEE AND RETRIEVED THE BROKEN PIECE. A C-ARM X-RAY WAS USED TO VERIFY THAT ALL PIECES WERE RETRIEVED. THE PHYSICIAN CONFIRMED RETRIEVAL OF THE BROKEN PIECE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. HOWEVER, THERE WAS NO PATIENT INJURY REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10775613 ↗
• InjuryJan 21, 2020Break; Break

  IT WAS REPORTED THE SHAVER BLADE BROKE APART INSIDE THE PATIENT. THEY HAD TO CONVERT TO OPEN TO RETRIEVE THE PIECE. SURGERY TIME WAS INCREASED FOR RETRIEVAL OF THE BROKEN PIECE, HOWEVER A HIGHER LEVEL OF SEDATION WAS NOT REQUIRED. THERE WAS NO HARM TO THE PATIENT. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9613099 ↗
• MalfunctionJan 7, 2020Break; Break

  IT WAS REPORTED THE TIP BROKE OFF IN PATIENT'S JOINT. LARGER INCISION AND X-RAY WERE NOT NEEDED TO RETRIEVE THE PIECE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT 5 MINUTES TO RETRIEVE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9561000 ↗
• InjuryOct 21, 2019Break; Break

  IT WAS REPORTED THE TIP OF THE SHAVER BROKE OFF IN THE PATIENT DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY AND EXTENDED PROCEDURE TIME REPORTED WAS 20-30 MINUTES TO REMOVE. SOME ADDITIONAL ANESTHESIA WAS GIVEN TO KEEP THE PATIENT SEDATED. THE C ARM WAS BROUGHT IN TO LOCATE THE PIECE. THE PIECE WAS REMOVED WITH A GRASPER. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216555 ↗
• MalfunctionSep 26, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE SHAVER BROKE INSIDE THE PATIENT DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125030 ↗
• MalfunctionSep 20, 2019Break; Break

  IT WAS REPORTED THE SHAVER BROKE INSIDE THE PATIENT DURING THE PROCEDURE, IT WAS NOT DUE TO PRESSURE. THE TIP WAS RETRIEVED THROUGH THE SCOPE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT ONE MINUTE TO RETRIEVE THE TIP. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9101149 ↗
• MalfunctionSep 9, 2019Break; Noise, Audible; Break; Noise, Audible

  IT WAS REPORTED THAT THE CUSTOMER WAS SHAVING SOFT TISSUE AND THE ARTHROSCOPIC SHAVER STARTED MAKING A WEIRD NOISE SO THE DOCTOR TOOK IT OUT OF THE PATIENT'S SHOULDER TO INSPECT IT, TURNED IT ON AND THE DEVICE BROKE OUTSIDE OF THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976926 ↗
• MalfunctionSep 9, 2019Break; Noise, Audible; Break; Noise, Audible

  IT WAS REPORTED THAT THE CUSTOMER WAS SHAVING SOFT TISSUE AND THE ARTHROSCOPIC SHAVER STARTED MAKING A WEIRD NOISE SO THE DOCTOR TOOK IT OUT OF THE PATIENT'S SHOULDER TO INSPECT IT, TURNED IT ON AND THE DEVICE BROKE OUTSIDE OF THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8975905 ↗
• MalfunctionAug 19, 2019Break; Break

  IT WAS REPORTED THE TIP BROKE OFF THE SHAVER DURING THE KNEE SCOPE. THE COMPLAINANT WAS NOT AWARE OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. THE EXTENDED PROCEDURE TIME WAS JUST THE TIME IT TOOK TO RETRIEVE THE PIECE. THE COMPLAINANT WAS NOT AWARE OF THE LENGTH OF EXTENDED PROCEDURE TIME. THE TIP FELL INTO THE PATIENT AND WAS RETRIEVED WITH AN ARTHROSCOPIC GRASPER. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8907973 ↗
• MalfunctionAug 9, 2019Break; Break

  IT WAS REPORTED THE SHAVER BLADE BROKE OFF. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE LENGTH OF EXTENDED PROCEDURE TIME WAS NOT REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE. MULTIPLE ATTEMPTS WERE MADE TO THE FACILITY FOR ADDITIONAL INFORMATION, HOWEVER NONE WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8881111 ↗
• MalfunctionJul 16, 2019Break; Break

  IT WAS REPORTED THE TIP OF THE SHAVER BROKE OFF IN THE PATIENT. THE TIP WAS RETRIEVED WITH A GRASPER WITHOUT ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793736 ↗
• MalfunctionJul 2, 2019Break; Break

  IT WAS REPORTED THE ARTHROSCOPIC SHAVER TIP BROKE OFF IN THE JOINT DURING AN ARTHROSCOPY. THERE WAS NO HARM TO THE PATIENT AND THE TIP WAS RETRIEVED WITH GRASPERS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE FACILITY CONTACT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755076 ↗
• MalfunctionJun 6, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE ARTHROSCOPIC SHAVER BROKE INSIDE THE PATIENT'S SHOULDER. THE DEVICE WAS REMOVED AND THE BROKEN PIECE WAS RETRIEVED WITH A GRASPER. A NEW SHAVER WAS OBTAINED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL TO REPLACE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674863 ↗
• MalfunctionMay 30, 2019Break; Break

  IT WAS REPORTED THAT THE ARTHROSCOPIC SHAVER TIP BROKE OFF WHILE IN USE. THE TIP WAS REMOVED FROM THE PATIENT WITH A GRASPER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINANT IS UNAWARE OF HOW LONG THE SURGICAL DELAY WAS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656090 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012635. One submission often covers many models, so check the product and lot details in each record.

• Z-0958-2012 · Jan 26, 2009 · Terminated
  ***CAT 275-534-000***STRYKER***Arthroscopic Blade***3.5mm AGGRESSIVE PLUS***Yellow/Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakelan
• Z-0954-2012 · Jan 26, 2009 · Terminated
  ***CAT 275-542-000***STRYKER***Arthroscopic Blade***4.0mm RESECTOR***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot nu
• Z-0957-2012 · Jan 26, 2009 · Terminated
  ***CAT 375-544-000***STRYKER***Arthroscopic Blade***4.0mm AGGRESSIVE PLUS***Hub Style - Formula***Red/Lt Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCA
• Z-0956-2012 · Jan 26, 2009 · Terminated
  ***CAT 375-545-000***STRYKER***Arthroscopic Blade***4.0mm TOMCAT CUTTER***Hub Style - Formula***Red/White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE S
• Z-0955-2012 · Jan 26, 2009 · Terminated
  ***CAT 275-941-000***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR Hollow 6 Flute***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakela
• Z-0960-2012 · Jan 26, 2009 · Terminated
  ***CAT 375-941-000***STRYKER***Arthroscopic Bur***4.0mm BARREL BUR***Hollow 6 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakel
• Z-0961-2012 · Jan 26, 2009 · Terminated
  ***CAT 375-941-012***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR***Hollow 12 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lak
• Z-0959-2012 · Jan 26, 2009 · Terminated
  ***CAT 375-532-000***STRYKER***Arthroscopic Blade***3.5mm RESECTOR***Hub Style - Formula***Yellow/Black***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOL