NA 72203160Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010656018), received between Dec 11, 2017 and May 18, 2026 — classified as 13 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER INSTABILITY REPAIR, DURING USE OF THE TWIST DRILL, THE DISTAL PART DETACHED AND FELL INSIDE THE PATIENT. THE DETACHED PART WAS REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203148 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT, DURING A BANKART REPAIR, TWO (2) TWIST FLEX DRILL BITS BROKE OFF. ONE OF THEM SNAPPED AT THE TIP AND BECAME LODGED IN THE PATIENT, THE BROKEN PIECE WAS EXTRACTED BY USING THE DRILL GUIDE AND THEN TWISTING IT OUT WITH A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010440 ↗
• InjuryJan 5, 2026Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE DISTAL TIP OF THE TWIST DRILL FLEX HAD BROKEN AND THE BROKEN PIECE COULD NOT BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A 15 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23967152 ↗
• InjuryNov 19, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE DISTAL TIP OF ONE (1) TWIST DRILL FLEX BROKE DURING THE FIRST DRILLING. THERE WAS A PIECE LEFT IN THE PATIENT BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23598624 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, WHEN DRILLING, THE DRILL BIT SEPARATED FROM THE SHAFT OF A TWIST DRILL FLEX. THE PROCEDURE WAS RESUMED, WITH A CHANGE IN SURGICAL TECHNIQUE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442283 ↗
• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ABR PROCEDURE, IT WAS NOTICED THAT WHEN THE SURGEON WAS DRILLING THE TWIST DRILL FLEX CRVD FOR 2.3 SA CAME OFF FROM THE DRILL´S JOINT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364337 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT THE TWIST DRILL FLEX DISTAL TIP HAD BROKEN DURING AN ARTHROSCOPY. ALL THE BROKEN PIECES COULD BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN S+N BACKUP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748953 ↗
• InjuryMar 26, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DRILL GUIDE BROKE INSIDE THE BONE WHILE DRILLING. THE DRILL COULD NOT BE REMOVED AND REMAINED INSIDE THE GLENOID BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21694789 ↗
• InjuryMay 15, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, WHEN THE FLEXIBLE TWIST DRILL WAS PULLED BACK, THE TIP BROKE IN THE BONE. ALL PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH A SURGICAL CLAMP. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD IN A NEW DRILLED HOLE, WITH A DELAY GREATER THAN 30 MINUTES. NO VOID WAS LEFT IN THE PATIENT, AND THE SURGEON WAS ULTIMATELY SATISFIED WITH THE SURGICAL OUTCOME. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19327616 ↗
• InjuryApr 18, 2024Break; Break

  IT WAS REPORTED THAT, DURING A LABRAL REPAIR PROCEDURE, TWO (2) FLEXIBLE TWIST DRILL DEVICES BROKE IN THE FLEXIBLE PORTION OF THE DRILL. FOR THE FIRST DEVICE, ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. FOR THE SECOND DEVICE, A PIECE STAY LODGED SECURED IN THE GLENOID. NO VOID WAS LEFT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, WHICH WAS USED IN AN ADDITIONAL DRILLED BONE HOLE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 19133648 ↗
• InjuryMar 27, 2024Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER DISLOCATION SURGERY, WHEN THE TWIST DRILL FLEX WAS USED TO DRILL A BONE HOLE, THE DEVICE BROKE . ALL BROKEN PIECES WERE REMOVED BY SUCTION. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN AN ADDITIONALLY DRILLED BONE HOLE, A VOID WAS LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD, DISCHARGED FROM THE HOSPITAL.

  Patient problems: Perforation

  MAUDE report 18989872 ↗
• MalfunctionFeb 19, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DISTAL TIP OF THE TWIST DRILL FLEX BROKE WHEN DRILLING INTO THE GLENOID FOSSA. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 40 MINUTES, AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18732038 ↗
• InjuryFeb 13, 2023Break; Break

  IT WAS REPORTED THAT AFTER A PROCEDURE, WHERE A TWIST DRILL FLEX WAS USED, A FOLLOW UP X-RAY THAT WAS MADE TO THE PATIENT DURING HIS POST-OPERATORY PROCESS, SHOWED THE PHYSICIAN BROKE THE TIP OFF THE TWIST DRILL IN THE PATIENT´S HIP, HOWEVER THE PHYSICIAN DID NOT NOTICE THIS AT THE TIME OF THE PROCEDURE, ONLY AFTER THE X-RAY TOOK PLACE. A CT SCAN WAS ORDERED BY THE PHYSICIAN TO ACKNOWLEDGE IF THIS ISSUE COULD BE PROBLEMATIC, AND IT WAS DETERMINED THAT THIS EVENT COULD RESULT BEING A POSSIBLE ISSUE TO THE PATIENT IF ANOTHER MRI WERE TO BE NEEDED AT SOME POINT. THE PATIENT´S CURRENT HEALTH CONDITION IS GOOD, RECOVERING FROM THE PROCEDURE WITHOUT ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16361474 ↗
• InjuryOct 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC LABRUM REPAIR WITH BIORAPTOR CURVED, RIGHT AFTER STARTING TO DRILL THE BONE, THE DISTAL PART OF THE "TWIST DRILL FLEX CURVED FOR 2.3MM SA" BROKE AND STAYED WITHIN THE HUMERAL HEAD. THE BROKEN PART WAS REMOVED WITH DIFFICULTY USING A GRASPER AND VARIOUS INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE INTO THE SAME BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583220 ↗
• InjuryMar 25, 2021Break; Break

  IT WAS REPORTED THAT DURING A DISLOCATION SURGERY, WHEN PULLING OUT THE TWIST DRILL AFTER MAKING THE BONE HOLE, THE DRILL BROKE INSIDE THE PATIENT AND IT REMAINED STUCK INTO THE GLENOID. THE BROKEN PIECES WERE REMOVED BY USING FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE WITH NO SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567735 ↗
• InjuryFeb 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY THE TWIST DRILL FLEX CRVD BROKE INSIDE THE PATIENT. THE SURGEON TRIED TO REMOVE THE REMAINS OF THE PIECE FROM THE PATIENT; HOWEVER IT WAS NOT POSSIBLE SINCE IT WAS IN A NARROW SPACE. THE PROCEDURE WAS COMPLETED BY USING A SMITH + NEPHEW BACKUP DEVICE WITH A DELAY OF LESS THAN OR EQUAL TO 30 MIN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345423 ↗
• MalfunctionNov 13, 2020Break; Break

  IT WAS REPORTED THAT DURING LATARJET SURGERY, THE SURGEON INSERTS THE DRILL AND STARTS DRILLING, IT MAKES TWO TURNS AND THEN MAKES A "CRACK" SOUND, SEEMS LIKE THE DRILL TIP GOT BLOCKED IN THE BONE WHILE DRILLING AND THE WHOLE DRILL SHAFT GOT TWISTED AND BROKE AT 2MM ABOVE THE CORTICAL BONE, WITH THE DISTAL TIP STILL IN THE PATIENT'S BONE. THE SURGEON TRIES AROUND 30 MIN TO REMOVE IT, UNSUCCESSFULLY. HE DECIDES TO KEEP ON WITH THE SURGERY AND COME BACK TO IT LATER TO TRY TO REMOVE IT. HE FIXES HIS POSTERIOR LABRUM, PERFORMS HIS LATARJET AND WHEN DONE HE COMES BACK TO TRY TO REMOVE THE DISTAL TIP STILL WITHIN THE BONE, IT TAKES 1.30 ADDITIONAL HOURS FOR THE SURGEON TO FIND A WAY TO REMOVE THE DRILL TIP, COULD NOT TAKE IT OUT BY PULLING ON IT, SO THE SURGEON HAD TO REMOVE SOME CORTICAL BONE AROUND, AND THEN PUSH IT FORWARD IN AN OBLIQUE WAY. HE FINALLY MANAGES TO REMOVE THE TIP. THE SURGEON USED ANOTHER PORTAL (MORE SUPERIOR) FOR FIXATION AS HE DID NOT WANT TO REUSE A FLEXIBLE DRILL BIT ON THIS PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10836324 ↗
• InjuryMay 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE TWIST DRILL FLEX BROKE INSIDE THE PATIENT, WHEN IT WAS REMOVED THE DISTAL TIP WAS GONE AND FLEXIBLE PORTION WAS FRAYED. THE ANCHOR WAS INSERTED WITH NO ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10031328 ↗
• InjuryApr 27, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY THE TWIST DRILL GAVE OF LOTS OF METAL DEBRIS WHEN DRILLING ANCHOR HOLES, ALL THE METAL WAS REMOVED FROM THE JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. A DELAY OF 5 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9999626 ↗
• MalfunctionNov 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER LIP REPAIR PROCEDURE, THE FLEXIBLE DRILL BROKE DURING PULL OUT THE DRILL. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT AND 3 HOURS DELAY WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK-UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9302720 ↗
• MalfunctionAug 14, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SURGEON WAS DRILLING THROUGH DRILL GUIDE AND THE DRILL WAS PULLED OUT, THE DRILL WAS HARD TO PULL BACK OUT AND THE TIP OF THE DRILL BROKE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: Foreign Body In Patient

  MAUDE report 8895071 ↗
• MalfunctionMay 10, 2019Break; Difficult to Remove

  IT WAS REPORTED THAT THE DRILL TIP BROKE INSIDE THE PATIENT AND COULD NOT BE REMOVED. PROCEDURE COMPLETED WITH THE SAME DEVICE NO DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8601413 ↗
• InjuryFeb 8, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT TO REMOVE A BROKEN DRILL TIP THAT WAS LEFT DURING A BANKART REPAIR PROCEDURE PERFORMED IN (B)(6) 2018. A MINI C ARM WAS USED TO LOCALIZE THE RETAINED FOREIGN BODY. ONCE IDENTIFIED, IT WAS REMOVED WITH A GRASPER. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 8323581 ↗
• MalfunctionAug 12, 2018Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE SURGEON WAS DRILLING, THE CHUCK OCCASIONALLY CAME OFF AND THE TIP OF DRILL BROKE, REMAINING IN THE PATIENT. THE SURGEON DECIDED TO LEAVE THE PIECE IN THE PATIENT. BROKEN PIECE MOVED FROM ITS ORIGINAL POSITION, THEREFORE SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2018 TO REMOVE THE REMAINING DRILL TIP AND PREVENT ANY OTHER COMPLICATION ON THE PATIENT. PATIENT CURRENT CONDITION IS GOOD.

  Patient problems: No Code Available

  MAUDE report 7775818 ↗
• MalfunctionFeb 6, 2018Break; Component Missing

  IT WAS REPORTED THAT DRILL BIT BROKE DURING SHOULDER REPAIR. DRILL BIT WAS LOOKED FOR OVER AN HOUR BUT IT COULD NOT BE FOUND. PATIENT FAMILY WAS ADVISED AND THEN 3 MORE HOURS WERE SPENT LOOKING FOR IT WITH PATIENT OPEN. DEVICE WAS NOT FOUND AFTER 6 HOURS. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7245666 ↗