CONMED 00507118100Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10845854009086), received between May 10, 2018 and May 15, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (23 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050") DEVICE WAS USED IN AN UNNAMED PROCEDURE ON APPROXIMATELY ON (B)(6) 2026, AND "THE TOOTH OF THE SAW BLADE HAS BROKEN OFF AFTER USE. REMOVED DEBRIS FROM THE SURGICAL SITE AND IRRIGATED / FLUSHED WITH SALINE SOLUTION.". THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATION, AND WITH A DELAY OF 2 MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185241 ↗
• MalfunctionMay 20, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿MOST OF THE BLADES BREAK AT THE SAME SPOT.¿. FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." ALL FRAGMENTATION WAS RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051341 ↗
• MalfunctionMay 20, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿MOST OF THE BLADE'S BREAK AT THE SAME SPOT.¿ FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." ALL FRAGMENTATION WAS RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051291 ↗
• MalfunctionMay 20, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿MOST OF THE BLADE'S BREAK AT THE SAME SPOT.¿. FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." ALL FRAGMENTATION WAS RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051158 ↗
• MalfunctionMay 19, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿MOST OF THE BLADES BREAK AT THE SAME SPOT.¿. FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." ALL FRAGMENTATION WAS RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043002 ↗
• MalfunctionMay 19, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿MOST OF THE BLADES BREAK AT THE SAME SPOT.¿. FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." ALL FRAGMENTATION WAS RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043001 ↗
• MalfunctionMay 19, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿MOST OF THE BLADE'S BREAK AT THE SAME SPOT.¿. FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." ALL FRAGMENTATION WAS RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042929 ↗
• MalfunctionMay 19, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿MOST OF THE BLADE'S BREAK AT THE SAME SPOT.¿. FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." ALL FRAGMENTATION WAS RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042926 ↗
• MalfunctionMay 16, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿MOST OF THE BLADES BREAK AT THE SAME SPOT.¿. FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." THE FRAGMENTS FELL INTO THE SURGICAL SITE AND WERE RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF IMPACT OR INJURY FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034371 ↗
• MalfunctionMay 16, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿MOST OF THE BLADES BREAK AT THE SAME SPOT.¿. FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." THE FRAGMENTS FELL INTO THE SURGICAL SITE AND WERE RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF IMPACT OR INJURY FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034370 ↗
• MalfunctionMay 16, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, "MOST OF THE BLADE'S BREAK AT THE SAME SPOT." FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." THE FRAGMENTS FELL INTO THE SURGICAL SITE AND WERE RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF IMPACT OR INJURY FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034369 ↗
• MalfunctionMay 16, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 00507118100, OSCILLATOR BLADE, 19.5 X 86 X 1.27 MM (.050"), WAS BEING USED DURING A KNEE SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿MOST OF THE BLADES BREAK AT THE SAME SPOT.¿. FURTHER ASSESSMENT FOUND THAT THE "TIP OF THE BLADE BROKE IN TWO (SNAPPED)." THE FRAGMENTS FELL INTO THE SURGICAL SITE AND WERE RETRIEVED WITH PLIERS. THERE WAS NO REPORT OF IMPACT OR INJURY FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034334 ↗
• MalfunctionDec 11, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 00507118100, 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5, WAS BEING DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿DURING TOTAL KNEE ARTHROPLASTY, SURGEON NOTICED TEETH FROM THE BLADE HAD FALLEN OFF AND INTO THE PATIENT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER. THE REPORTER ALSO STATED, ¿BLADE TEETH WERE ALL LOCATED AND REMOVED.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299969 ↗
• MalfunctionNov 28, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00507118100 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5 WAS BEING USED ON 31OCT23 AND ¿DURING HIP PROTHESYS SURGERY, ONE TOOTH OF THE BLADE BROKE WHEN CUTTING THE BONE. SAW HANDPIECE USED PRO9300B.¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT THE FRAGMENT DID FALL INTO THE SURGICAL SITE AND WAS RETRIEVED. THERE WAS NO IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. THE PRO9300B HALL TITAN OSCILLATING SAW BATTERY HANDPIECE WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE WAS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220410 ↗
• MalfunctionNov 28, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00507118100 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5 WAS BEING USED ON AN UNKNOWN DATE AND ¿DURING HIP PROTHESYS SURGERY, ONE TOOTH OF THE BLADE BROKE WHEN CUTTING THE BONE. SAW HANDPIECE USED PRO9300B.¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT THE FRAGMENT DID FALL INTO THE SURGICAL SITE AND WAS RETRIEVED. THERE WAS NO IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. THE PRO9300B HALL TITAN OSCILLATING SAW BATTERY HANDPIECE WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE WAS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220377 ↗
• MalfunctionSep 26, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00507118100, 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5 WAS BEING USED ON (B)(6) 2023 AND "THREE BURS BROKE WHILE IN USE". AFTER FURTHER ASSESSMENT IT WAS FOUND, "DURING PTG SURGERY, A TOOTH OF THE BLADE BREAKS WHEN CUTTING THE FEMUR AND THE PIECE IS RECOVERED INTRA-ARTICULAR." THERE WAS NO IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819355 ↗
• MalfunctionSep 26, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00507118100, 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5 WAS BEING USED ON 12SEP23 AND ¿THREE BURS BROKE WHILE IN USE¿. AFTER FURTHER ASSESSMENT IT WAS FOUND, "DURING PTA SURGERY, A BROKEN TOOTH OF THE BLADE WAS SEEN AFTER X-RAY. NO SECOND SURGERY REQUIRED ¿ BROKEN FRAGMENT WAS SEEN WITH XRAY WHEN THE SURGICAL SITE WAS STILL OPEN AND REMOVED RIGHT AFTERWARDS. NO FRAGMENTS WAS LEFT IN PATIENT¿. THERE WAS NO IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819346 ↗
• MalfunctionJul 13, 2023Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 00507118100, 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY,5, WAS BEING USED DURING A TOTAL KNEE PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿BLADE TOOTH BROKE OFF AND MIDDLE TOOTH BENT.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS RETRIEVED WITH THE USE OF FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320501 ↗
• MalfunctionApr 5, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE 00507118100 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5 WAS BEING USED ON (B)(6) 2023 AND THE BLADE BROKE. THE PROCEDURE WAS COMPLETED. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE DEVICE DID FRAGMENT AND FALL INTO SURGICAL SITE. THE FRAGMENT WAS RETRIEVED. "TOWARDS THE END OF THE PROCEDURE, THE SURGEON WAS USING THE TIP OF THE BLADE TO ¿FLICK¿ OUT BONE DEBRI AND CHIPS. IN DOING SO THE FURTHER TOOTH ON THE END OF THE BLADE BROKE OFF. IT DID NOT IMPACT THE PATIENT OR CAUSE INJURY, AND THE BROKEN PIECE WAS REMOVED FROM THE BLADE." THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684007 ↗
• MalfunctionAug 30, 2021Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 00507118100 WAS BEING USED DURING A TOTAL KNEE REPLACEMENT ON (B)(6) 2021 WHEN IT WAS REPORTED CUSTOMER COMPLAINED THAT ONE BRAND NEW SAW BLADE CHIPPED AT CORNER WHEN SAWING PROCEDURE WAS DONE. UPON RETRIEVING THE SAW BLADE, THE SURGEON NOTICED THAT THE SERRATED TOOTH WAS CHIPPED OFF. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR THE USER. THE PROCEDURE WAS COMPLETED AS PLANNED WHILE USING A SAME-LIKE DEVICE AS AN ALTERNATE. FURTHER ASSESSMENT QUESTIONS WERE SENT TO THE DISTRIBUTOR; AND WE WERE ADVISED THAT ALL FRAGMENTS WERE REMOVED FROM THE PATIENT USING A NON-TOOTH FORCEPS. THE PATIENT WAS LISTED AS DOING FINE. THE INCIDENT CAUSED A 3-MINUTE DELAY IN THE PROCEDURE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385424 ↗
• MalfunctionAug 30, 2021Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 00507118100 WAS BEING USED DURING A TOTAL KNEE REPLACEMENT ON (B)(6) 2021 WHEN IT WAS REPORTED CUSTOMER COMPLAINED THAT ONE BRAND NEW SAW BLADE CHIPPED AT CORNER WHEN SAWING PROCEDURE WAS DONE. UPON RETRIEVING THE SAW BLADE, THE SURGEON NOTICED THAT THE SERRATED TOOTH WAS CHIPPED OFF. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR THE USER. THE PROCEDURE WAS COMPLETED AS PLANNED WHILE USING A SAME-LIKE DEVICE AS AN ALTERNATE. FURTHER ASSESSMENT QUESTIONS WERE SENT TO THE DISTRIBUTOR; AND WE WERE ADVISED THAT ALL FRAGMENTS WERE REMOVED FROM THE PATIENT USING A NON-TOOTH FORCEPS. THE PATIENT WAS LISTED AS FINE AND DISCHARGED. THE INCIDENT CAUSED A 5-MINUTE DELAY IN THE PROCEDURE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385342 ↗
• MalfunctionAug 30, 2021Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 00507118100 WAS BEING USED DURING A TOTAL KNEE REPLACEMENT ON (B)(6) 2021 WHEN IT WAS REPORTED CUSTOMER COMPLAINED THAT ONE BRAND NEW SAW BLADE CHIPPED AT CORNER WHEN SAWING PROCEDURE WAS DONE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR THE USER. THE PROCEDURE WAS COMPLETED AS PLANNED WHILE USING A SAME-LIKE DEVICE AS AN ALTERNATE. FURTHER ASSESSMENT QUESTIONS WERE SENT TO THE DISTRIBUTOR; AND WE WERE ADVISED THAT ALL FRAGMENTS WERE REMOVED FROM THE PATIENT USING A NON-TOOTH FORCEPS. THE PATIENT WAS LISTED AS FINE AND DISCHARGED. THE INCIDENT CAUSED A 5-MINUTE DELAY IN THE PROCEDURE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385268 ↗
• MalfunctionAug 30, 2021Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 00507118100 WAS BEING USED DURING A TOTAL KNEE REPLACEMENT ON (B)(6) 2021 WHEN IT WAS REPORTED CUSTOMER COMPLAINED THAT ONE BRAND NEW SAW BLADE CHIPPED AT CORNER WHEN SAWING PROCEDURE WAS DONE.. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR THE USER. THE PROCEDURE WAS COMPLETED AS PLANNED WHILE USING A SAME-LIKE DEVICE AS AN ALTERNATE. FURTHER ASSESSMENT QUESTIONS WERE SENT TO THE DISTRIBUTOR; AND WE WERE ADVISED THAT ALL FRAGMENTS WERE REMOVED FROM THE PATIENT USING A NON-TOOTH FORCEPS. THE PATIENT WAS LISTED AS FINE AND DISCHARGED. THE INCIDENT CAUSED A 5-MINUTE DELAY IN THE PROCEDURE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385205 ↗
• MalfunctionMay 10, 2018Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT THE 00507118100, 19.5 X 86 X 1.27 MM (.050 INCH) OSCILLATOR BLADE, QTY 5, BROKE DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2018. THIS OCCURRED WHILE THE SURGEON WAS CUTTING THE FEMUR WITH A GUIDE. THE BREAKAGE WAS REMOVED FROM THE SURGICAL SITE CAUSING A SLIGHT DELAY IN THE PROCEDURE. IT IS REPORTED THAT THERE WAS NOT ANY SURGICAL INTERVENTION REQUIRED FOR THIS INCIDENT AND NEITHER THE PATIENT NOR THE USER SUSTAINED ANY INJURY CAUSED BY THE BREAKAGE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502120 ↗
• MalfunctionMay 10, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE (B)(4), 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, QTY 5, BROKE DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2018. THIS OCCURRED WHILE THE SURGEON WAS CUTTING THE FEMUR WITH A GUIDE. THE BREAKAGE WAS REMOVED FROM THE SURGICAL SITE CAUSING A SLIGHT DELAY IN THE PROCEDURE. IT IS REPORTED THAT THERE WAS NOT ANY SURGICAL INTERVENTION REQUIRED FOR THIS INCIDENT AND NEITHER THE PATIENT NOR THE USER SUSTAINED ANY INJURY CAUSED BY THE BREAKAGE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502107 ↗