LIGHTNING, STERLING H9133Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10845854029671), received between Aug 9, 2018 and Mar 21, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE H9133, 4.5MM STERLING, LIGHTNING, 6 EA WAS USED DURING AN ELBOW ARTHROSCOPY ON THE DATE OF (B)(6) 2023, WHEN IT WAS REPORTED, ¿DURING THE SURGICAL PROCEDURE THE BLADE BENT AND BROKEN IN AN ABNORMAL WAY, THE SAME THING HAPPENS WHEN OPENING OTHER PIECES SAME LOT.¿. AFTER FURTHER ASSESSMENT IT WAS CONCLUDED THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE, BUT IT WAS RETRIEVED WITH A BASKET GRASPER. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN ALTERNATE DEVICE AND A 30 MINUTE DELAY. THERE WAS NO PATIENT OR USER INJURY, PROLONGED HOSPITALIZATION, OR MEDICAL INTERVENTION. 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 16588496 ↗
• MalfunctionMar 12, 2019Break; Break

  THE CUSTOMER REPORTED THE H9133, STERLING LIGHTNING SHAVER BLADE, BROKE DURING SURGERY. THERE WERE NO ISSUES INSERTING THE SHAVER INTO THE HANDPIECE. THERE WERE NO FRAGMENTS THAT FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED AND A DELAY OF 2-MINUTES FOR SURGERY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8411589 ↗
• MalfunctionDec 20, 2018Break; Break

  THE CUSTOMER REPORTED THAT THE H9133, ARTHROSCOPIC BUR SEPARATES FROM THE HUB DURING USE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE BUR WAS ABLE TO BE USED FOR UP TO 2 MINUTES BEFORE COMING APART. THIS WAS DURING A SHOULDER ARTHROSCOPY. THE BUR WAS NOT PRE-TESTED, THEY DID COMPLETE THE SURGERY AS PLANNED BY OPENING ANOTHER BUR. THERE IS NO REPORTED PATIENT INJURY OR DELAY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184036 ↗
• MalfunctionOct 9, 2018Break; Break

  THE CONMED REPRESENTATIVE REPORTED THAT THE INNER CUTTING BLADE DETACHED FROM INNER HUB AND WOULD NOT SPIN. NO INJURY TO THE PATIENT IS REPORTED. THIS REPORT IS BEING RAISED BASED ON A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948643 ↗
• MalfunctionOct 9, 2018Break; Break

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE DOCTOR THAT THE SHEATH OF THE BUR, H9133, IS COMING OFF THE DEVICE WHILE INSIDE OF THE JOINT. THERE WAS NO REPORT OF PATIENT OR USER INJURY AND THE PROCEDURE WAS COMPLETED USING ANOTHER BUR. THIS REPORT IS BEING RAISED BASED ON A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948640 ↗
• MalfunctionOct 9, 2018Break; Break

  THE CONMED REPRESENTATIVE REPORTED THAT HIS CUSTOMER WAS USING THE H9133 BUR DURING A SHOULDER ACROMIOPLASTY AND IT FAILED WITHIN 23 SECONDS OF USE. THERE WAS NO FRAGMENTING, THE BUR STAYED INTACT. THERE WAS NO REPORTED PATIENT INJURY AND THE SURGERY WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED BASED ON A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948623 ↗
• MalfunctionSep 4, 2018Break; Break

  THE CUSTOMER REPORTED THE "H9133 - 4.5 MM STERLING, LIGHTNING, "DID NOT WORK PROPERLY DURING A PROCEDURE AND BROKE OFF, WHILE IN USE ". THIS WAS REPORTED WITH NO PATIENT INJURY OR SURGICAL DELAY. BASED ON THE DECISION TREE RESULTS AND PROVIDED INFORMATION, THIS WILL BE REPORTED AS A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7842112 ↗
• MalfunctionAug 31, 2018Break; Break

  THE CUSTOMER REPORTED THE "H9133 - 4.5 MM STERLING, LIGHTNING, "DID NOT WORK PROPERLY AND BROKE OFF". THIS WAS REPORTED WITH NO PATIENT INJURY OR SURGICAL DELAY. BASED ON THE DECISION TREE RESULTS AND PROVIDED INFORMATION, THIS WILL BE REPORTED AS A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7838737 ↗
• MalfunctionAug 28, 2018Break; Break

  THE CUSTOMER REPORTED THAT 3 "H9133 - 4.5 MM STERLING, LIGHTNING, BLADES CAME LOOSE FROM WHERE IT ENGAGES IN THE HUB. IT COMES APART BEFORE TOUCHING THE BONE". THIS WAS REPORTED WITH NO PATIENT INJURY BUT A 30-MINUTE SURGICAL DELAY. FURTHER ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, NO OTHER INFORMATION WAS MADE AVAILABLE. BASED ON THE DECISION TREE RESULTS AND PROVIDED INFORMATION, THIS WILL BE REPORTED AS A DEVICE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7823465 ↗
• MalfunctionAug 28, 2018Break; Break

  THE CUSTOMER REPORTED THAT 2 "H9133 - 4.5MM STERLING, LIGHTNING, BLADES CAME LOOSE FROM WHERE IT ENGAGES IN THE HUB. IT COMES APART BEFORE TOUCHING THE BONE". THIS WAS REPORTED WITH NO PATIENT INJURY BUT A 30-MINUTE SURGICAL DELAY. FURTHER ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, NO OTHER INFORMATION WAS MADE AVAILABLE. BASED ON THE DECISION TREE RESULTS AND PROVIDED INFORMATION, THIS WILL BE REPORTED AS A DEVICE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7823462 ↗
• MalfunctionAug 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT 3 "H9133 - 4.5 MM STERLING, LIGHTNING, BLADES CAME LOOSE FROM WHERE IT ENGAGES IN THE HUB. IT COMES APART BEFORE TOUCHING THE BONE". THIS WAS REPORTED WITH NO PATIENT INJURY BUT A 30-MINUTE SURGICAL DELAY. FURTHER ASSESSMENT REVEALED THAT THE SHAFT WAS COMING LOOSE FROM THE HUB, SO WHEN THE SHAVER WAS TURNED ON THE HUB WOULD SPIN BUT THE SHAVER WOULD NOT. THERE WERE NO ISSUES IN PLACING THE BURS INTO THE HANDPIECE. BASED ON THE DECISION TREE RESULTS AND PROVIDED INFORMATION, THIS WILL BE REPORTED AS A DEVICE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7798979 ↗
• MalfunctionAug 13, 2018Break; Break

  THE CUSTOMER REPORTED THAT H9133, 4.5MM STERLING, LIGHTNING, 6 EA, DEVICE CAME APART DURING A SUBACROMIAL DECOMPRESSION PROCEDURE ON (B)(6) 2018. THE EVENT DID NOT CAUSE ANY DELAY OR CANCELLATION OF THE PROCEDURE. NO COMPONENT OF THE DEVICE CAME INTO CONTACT WITH THE PATIENT. THERE WAS NO REPORT OF INJURY TO PATIENT OR USER. ANOTHER H9133 DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 7777689 ↗
• MalfunctionAug 9, 2018Activation Problem; Activation Problem

  THE CUSTOMER REPORTED THE "H9133 - 4.5 MM STERLING, LIGHTNING, "DID NOT WORK AS EXPECTED". FURTHER ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION, BUT NONE WAS PROVIDED. THIS WAS REPORTED WITH NO PATIENT INJURY OR SURGICAL DELAY. BASED ON THE DECISION TREE RESULTS AND PROVIDED INFORMATION, THIS WILL BE REPORTED AS A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7768334 ↗