N/A (REF 375-545-000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00885825014223), received between Nov 9, 2016 and May 31, 2023 — classified as 5 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (39 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THE DEVICE BROKE OFF DURING THE PROCEDURE AND THAT THE DOCTOR WAS ABLE TO RETRIEVE THE PART. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035281 ↗
• InjuryJan 31, 2022Break; Break

  IT WAS REPORTED THAT THE ITEM WAS USED DURING PROCEDURE. THE TIP OF THE ITEM SEEMINGLY BROKE OFF INSIDE THE PATIENT. THE PATIENT HAD TO HAVE A REVISION PROCEDURE AT ANOTHER FACILITY DUE TO DISCOMFORT. THE PIECE OF THE ITEM WAS RETRIEVED AND CURRENTLY IN THE FACILITIES' PATHOLOGY LAB. EXTENDED PROCEDURE TIME WAS REPORTED. NO INFORMATION WAS PROVIDED REGARDING THE LENGTH OF THE EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13392813 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED A CUTTER BROKE DURING A CASE. THE PATIENT WAS NOT COMPROMISED AND THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE. 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: Insufficient Information

  MAUDE report 12551102 ↗
• MalfunctionSep 3, 2021Break; Break

  IT WAS REPORTED THE SHAVER TIP BROKE OFF DURING THE ARTHROSCOPY SHOULDER SUBACROMIAL DECOMPRESSION CASE. THE TIP FELL IN THE PATIENT AND WAS RETRIEVED WITH AN ARTHROSCOPIC GRASPER. IT WAS REPORTED IT TOOK 10 SECONDS TO RETRIEVE THE PIECE. THE DEVICE WAS USED FOR 5 MINUTES PRIOR TO BREAKAGE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 2 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422436 ↗
• MalfunctionJul 28, 2021Break

  IT WAS REPORTED DURING A KNEE ARTHROSCOPY THE TOMCAT CUTTER TIP BROKE OFF IN THE PATIENT. THE SURGEON WAS SUCCESSFULLY ABLE TO RETRIEVE THE BROKEN PIECE OUT OF THE KNEE CAVITY USING METAL FORCEPS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 5 MINUTES. THE BROKEN PIECE WAS RETRIEVED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242240 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF THE CUTTING BLADE OF THE ARTHROSCOPIC SHAVER BROKE OFF INSIDE THE PATIENT. THE BROKEN TIP WAS RETRIEVED ARTHROSCOPICALLY USING A GRASPER WITHOUT X-RAY OR A LARGER INCISION. THE COMPLAINANT IS NOT AWARE OF ANY ADVERSE CONSEQUENCES. NO HARM TO THE PATIENT WAS NOTED. THERE WAS NO UNANTICIPATED MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME WAS APPROXIMATELY 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742271 ↗
• InjuryFeb 11, 2021Break; Break

  IT WAS REPORTED THAT THE ARTHROSCOPIC SHAVER FAILED DURING A PROCEDURE. THE PHYSICIAN WAS SHAVING SOME SOFT TISSUE IN A KNEE JOINT AND THE TIP OF THE INTERIOR ROTATING BLADE BROKE OFF AND HAD TO BE RETRIEVED VIA THE USE OF X-RAY. THE PROCEDURE WAS DELAYED 30 MINUTES IN ORDER TO X-RAY THE PATIENT¿S KNEE AND RETRIEVE THE BROKEN PIECE. 34 SECONDS OF FLUOROSCOPY WAS USED AND AN EXTRA 2 INCH INCISION HAD TO BE MADE IN ORDER TO RETRIEVE THE PIECE. THERE WERE NO ADVERSE EFFECTS NOTED, AND NO RESULTANT HEALTH COMPLICATIONS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318984 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED THAT THE TIP BROKE OFF THE ARTHROSCOPIC SHAVER WHILE IN USE. THE TIP WAS NOTICED IN THE PATIENT AFTER ROUGHLY TWENTY MINUTES OF USE. THE BROKEN PIECE WAS RETRIEVED WITH AN ARTHROSCOPIC GRASPER THROUGH THE EXISTING PORT SITES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME WAS 10 MINUTES TO RETRIEVE THE BROKEN PIECE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229703 ↗
• InjuryNov 6, 2020Break; Break

  IT WAS REPORTED THAT A PIECE OF THE ARTHROSCOPIC SHAVER TIP BROKE OFF IN THE PATIENT'S KNEE. RADIOLOGY WAS CALLED TO THE ROOM TO TAKE X-RAYS TO ENSURE THE PIECE WAS NOT STILL IN THE PATIENT'S KNEE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. HOWEVER, THERE WAS NO PATIENT INJURY OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10802147 ↗
• MalfunctionSep 9, 2020Break; Break

  IT WAS REPORTED THAT THE ARTHROSCOPIC SHAVER BROKE DURING THE PROCEDURE. THE PIECES THAT BROKE OFF WERE RETRIEVED. 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 Known Impact Or Consequence To Patient

  MAUDE report 10512386 ↗
• MalfunctionSep 9, 2020Break; Break

  IT WAS REPORTED THAT THE ARTHROSCOPIC SHAVER DEVICE BROKE DURING SURGERY AND PIECES OF THE DEVICE BROKE OFF. 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 Known Impact Or Consequence To Patient

  MAUDE report 10512373 ↗
• MalfunctionSep 9, 2020Break; Break

  IT WAS REPORTED THAT THE ARTHROSCOPIC SHAVER OSCILLATING BLADE BROKE OFF IN THE MIDDLE OF THE CASE AND THE BROKEN PIECE WAS RETRIEVED WITH A GRASPER. 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 10512370 ↗
• MalfunctionJun 9, 2020Break; Break

  IT WAS REPORTED THAT THE ARTHROSCOPIC SHAVER BROKE DURING THE CASE. THE DEVICE WAS REPLACED WITH ANOTHER ARTHROSCOPIC SHAVER. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 30 MINUTES. THE COMPLAINANT IS NOT AWARE OF ANY UNANTICIPATED MEDICAL INTERVENTION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136247 ↗
• MalfunctionApr 29, 2020Break; Break

  IT WAS REPORTED THAT A BURR FROM ARTHROSCOPIC SHAVER BROKE IN SURGICAL SITE. THE BROKEN PIECE WAS RETRIEVED WITH A GRASPER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 TO 10 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10010360 ↗
• MalfunctionApr 29, 2020Break; Break

  IT WAS REPORTED THAT A BURR FROM AN ARTHROSCOPIC SHAVER BROKE IN THE SURGICAL SITE. THE BROKEN PIECE WAS RETRIEVED WITH A GRASPER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 TO 10 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10010089 ↗
• MalfunctionApr 29, 2020Break; Break

  IT WAS REPORTED THAT A BURR FROM AN ARTHROSCOPIC SHAVER BROKE IN THE SURGICAL SITE. THE BROKEN PIECE WAS RETRIEVED WITH A GRASPER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 TO 10 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10010077 ↗
• MalfunctionFeb 26, 2020Break; Break

  IT WAS REPORTED THAT A PIECE OF THE ARTHROSCOPIC SHAVER SHAVER BROKE OFF IN THE PATIENT DURING SURGERY. THE BROKEN PIECE WAS RETRIEVED WITH AN ENDOSCOPE. THERE WAS NO PATIENT INJURY OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9759537 ↗
• MalfunctionSep 20, 2019Break; Break

  IT WAS REPORTED THAT THE SHAVER TIP CAME APART. THE SHAVER TIP FELL IN THE PATIENT AND WAS SUCCESSFULLY RETRIEVED WITH A LAPAROSCOPIC GRASPER WITHIN 5 MINUTES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9101144 ↗
• MalfunctionMar 21, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE ARTHROSCOPIC SHAVER DID NOT WORK. 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 8442075 ↗
• MalfunctionFeb 11, 2019Break; Break

  IT WAS REPORTED DURING RESECTION IN THE KNEE WITH THE ARTHROSCOPIC SHAVER, THE TIP OF THE BLADE CAME OFF. A GRASPER WAS USED TO RETRIEVE THE PIECE OF THE BLADE. IT WAS CONFIRMED THERE WERE NO PIECES LEFT. THERE WAS NO X-RAY NEEDED NOR LARGER INCISION MADE. THE DEVICE WAS REPLACED WITH A NEW DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL TO REMOVE BROKEN PIECE AND REPLACE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8326237 ↗
• MalfunctionDec 17, 2018Break; Break

  IT WAS REPORTED THE ARTHROSCOPIC SHAVER TIP BROKE OFF INSIDE THE PATIENT. THE PIECE WAS SUCCESSFULLY RETRIEVED AND DID NOT REQUIRE LARGER INCISION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL TO REPLACE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8169669 ↗
• MalfunctionNov 28, 2018Break; Break

  IT WAS REPORTED DURING A KNEE ARTHROSCOPY THAT THE ARTHROSCOPE SHAVER BROKE OFF INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN CUTTER USING FORCEPS AND RESUME SURGERY TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT THREE MINUTES TO RETRIEVE PIECE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8113680 ↗
• MalfunctionAug 30, 2018Break; Break

  IT WAS REPORTED THE ARTHROSCOPIC SHAVER TIP BROKE OFF IN THE PATIENT'S KNEE DURING THE PROCEDURE. THE PHYSICIAN RETRIEVED THE TIP WITH A GRASPER. THE DEVICE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7835899 ↗
• MalfunctionAug 9, 2018Break; Break

  IT WAS REPORTED THE TIP OF THE SHAVER FELL OFF OUTSIDE OF PATIENT. THE TIP BENT BACK AS THEY REMOVED IT THROUGH TROCAR AND TIP CAME OFF OUTSIDE OF PATIENT. LARGER INCISION AND X-RAY WERE NOT NEEDED TO LOCATE THE PIECE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT TWO MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7769987 ↗
• MalfunctionJul 26, 2018Break; Break

  IT WAS REPORTED THE ARTHROSCOPIC SHAVER BROKE OFF INTO MULTIPLE PIECES DURING SURGERY. THE PIECES WERE RETRIEVED AND REMOVED. ADDITIONAL ANESTHESIA WAS ADMINISTERED. IT IS UNKNOWN BY THE FACILITY HOW MUCH, HOWEVER, PATIENT WAS IN STABLE CONDITION. THERE WAS NO LARGER INCISION MADE AND IT IS UNKNOWN BY THE FACILITY IF X-RAY WAS DONE. DEVICE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 45 MINUTES TO RETRIEVE PIECES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7724893 ↗

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-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-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-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-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-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
• 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-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