NA 03.612.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10705034714486), received between Jun 30, 2017 and Apr 15, 2026 — classified as 2 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (12 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Compatibility Problem

  IT WAS REPORTED THAT THERE WAS A PRODUCT COMPATIBILITY ISSUE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886049 ↗
• MalfunctionMar 10, 2026Compatibility Problem

  IT WAS REPORTED THAT THE FLEX ARM NO LONGER HOLDS PROPERLY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558615 ↗
• MalfunctionDec 19, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHEN THE SURGEON TURNED THE SCREW ON THE FLEXIBLE ARM TO LOCK IT IN PLACE, IT NO LONGER WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853718 ↗
• MalfunctionDec 10, 2025Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PRE-OPERATIVE TESTING IT WAS DISCOVERED THAT THE FLEX ARM WAS MISSING FIXING BOLTS, HAD BROKEN BEARING, AND FLEXIBLE HOSE TENSIONER WING NUT WAS NOT LOCKED. ALSO THE RETRACTOR FRAME MEDIAL LATERAL WAS MISSING A FIXING BOLT AND ITS PRESSER FOOT HOLDER DID NOT HOLD POSITION. THE INSTRUMENTS WERE NOT USED DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771773 ↗
• MalfunctionNov 14, 2025Mechanical Problem; Mechanical Problem

  THE ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT IMPACT AND NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23557705 ↗
• MalfunctionNov 14, 2025Mechanical Problem; Mechanical Problem

  THE ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT IMPACT AND NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23557480 ↗
• MalfunctionNov 6, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE FLEX ARM STOPPED WORKING. WHEN ROTATING IT WON¿T GET FIXED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491147 ↗
• MalfunctionSep 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE FLEX ARM WAS NOT FULLY TIGHTENING AND SHOWED SOME LOOSENESS. THERE WAS NO IMPACT ON THE PATIENT AND NO DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23131632 ↗
• MalfunctionSep 10, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON AN UNKNOWN DATE IN (B)(6) 2025. THE FLEX ARM WAS NOT FULLY TIGHTENING AND SHOWED SOME LOOSENESS. THERE WAS NO IMPACT ON THE PATIENT AND NO DELAY. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020083 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW WAS BLOCKED ON THE FLEX ARM. THE EVENT OCCURRED DURING STERILE PROCESSING DURING FIELD INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT SURGERY WAS COMPLETED SUCCESSFULLY AND NO ADDITIONAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394925 ↗
• MalfunctionSep 24, 2024Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE FLEX ARM CLAMP WAS NOT CLOSING FULLY SO WOULD NOT GRIP ONTO THE ATTACHMENT ARM. OPTAPE WAS USED TO SECURE THE DEVICE IN PLACE. THERE WAS NO DELAY TO SURGERY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A FLEX ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291118 ↗
• MalfunctionFeb 1, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL PROCEDURE ON (B)(6) 2024, THE FLEX ARM WAS NOT SUFFICIENTLY TIGHTENING. THEREFORE, THE SURGEON TOOK THE OTHER FLEX ARM FROM THE SYSTEM AND CONTINUED WITH HIS CASE. THERE WAS NO DELAY OR PATIENT CONSEQUENCE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE FLEX ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622736 ↗
• MalfunctionJan 17, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A PROCEDURE THE FLEX ARM WOULD NOT BECOME RIGID UPON TIGHTENING THE HANDLE. IT COULD NOT BE UTILIZED. THERE WAS A FIVE (5) MINUTES OF SURGICAL DELAY, UNTIL THE SECOND SET WAS OPENED. THERE WAS NO PATIENT IMPACT. PROCEDURE WAS COMPLETED SUCCESSFULLY AS PLANNED. THIS REPORT IS FOR ONE (1) FLEX ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528360 ↗
• MalfunctionDec 22, 2023Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSIGHT RETRACTOR ARM NO LONGER TIGHTENS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY OR PATIENT CONSEQUENCES. THERE WAS NO GENERATION OF FRAGMENTS. THIS REPORT IS FOR A FLEX ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382866 ↗
• MalfunctionDec 21, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE SURGEON FOUND THAT THE FLEX ARM LOST ITS STIFFNESS AND WAS NO LONGER ADEQUATELY PERFORMING. HE USED THE SECOND FLEX ARM IN THE SET AND QUICKLY FIXED THE ISSUE. THE PATIENT WAS NOT IMPACTED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THIS REPORT INVOLVES ONE FLEX ARM. THIS IS REPORT 1 OF 1 FOR PC--(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372014 ↗
• MalfunctionDec 5, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS TIGHTENING THE FLEX ARM TO THE INSIGHT TUBE, AND FOUND THAT THE FLEX ARM WAS NO LONGER TIGHTENING. THE FLEX ARM WAS BROKEN AND NEEDS TO BE REPLACED. THE SURGEON USED THE OTHER FLEX ARM FROM THE SET AND COMPLETED THE CASE. THERE WAS NO DELAY OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE FLEX ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266828 ↗
• MalfunctionOct 10, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING AN MIS DECOMPRESSION SPINAL PROCEDURE ON (B)(6) 2023, THE MIS FLEX ARM WAS NOT LOOSENING. THE SURGEON USED THE OTHER FLEX ARM FOUND IN THE SET. THERE WAS NO PATIENT IMPACT, AND NO DELAY TO SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE FLEX ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906181 ↗
• MalfunctionJun 28, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE FLEX ARM WAS NOT REMAINING IN ITS STIFF POSITION. THE DEVICE WAS REMOVED FROM THE SET, AND THE SURGEON USED THE OTHER FLEX ARM FROM THE SET IN ORDER TO COMPLETE THE CASE. THE PATIENT WAS NOT IMPACTED, AND THERE WAS NO DELAY IN SURGERY. THIS REPORT INVOLVES ONE FLEX ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215511 ↗
• MalfunctionApr 12, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE MIS SUPPORT WAS NO LONGER MAINTAINING ITS STIFFNESS POSITION ONCE FULLY TIGHTENED. THE OTHER SUPPORT FROM THE SET WAS USED TO CONTINUE THE CASE. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE FLEX ARM. THIS IS REPORT 1OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726178 ↗
• MalfunctionOct 24, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE FLEX ARM WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) FLEX ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657454 ↗
• MalfunctionAug 16, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT CUSTOMER HAS A MIS FLEX ARM THAT IS BLOCKED INSIDE AND CAN'T BE MOVED. THE SURGEON USED THE OTHER FLEX ARM IN THE SET. CREATING NO DELAY AND NO IMPACT TO THE PATIENT. THIS REPORT IS FOR ONE (1) FLEX ARM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232624 ↗
• MalfunctionJan 5, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN POSTERIOR CERVICAL TUMOR REMOVAL PROCEDURE PERFORMED ON (B)(6), 2021, UPON OPENING THE SET THE SYNFRAME INSULATED TABLE CLAMP WAS COMPLETELY JAMMED/OVERTIGHTENED AND WAS UNUSABLE. AN ALTERNATIVE TABLE CLAMP WAS USED TO SOLVE THE PROBLEM. AFTER THAT IT WAS DISCOVERED THAT THE INSIGHT FLEX ARM CONTAINED WITHIN THE LOAN SET WOULDN¿T LOCK IN TO POSITION. IT REMAINED FLOPPY AND WOULDN¿T LOCK MAKING IT UNUSABLE. THE SURGEON WORKED AROUND THIS BY USING AN ALTERNATIVE RETRACTOR AND CONTINUED WITH THE OPERATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETE. THIS REPORT IS FOR ONE (1) FLEX ARM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169923 ↗
• MalfunctionJul 16, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE THE FLEX ARM WAS BROKEN. NO FRAGMENTS GENERATED. SPARE DEVICE WAS USED TO COMPLETED THE PROCEDURE. THERE WAS SURGICAL DELAY OF TWO (2) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) FLEX ARM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286517 ↗
• MalfunctionApr 1, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A MINIMALLY INVASIVE SURGERY (MIS) DECOMPRESSION OF THE SPINE WHILE SETTING UP THE FLEX ARM IT WOULD NOT HOLD IT'S POSITION. ANOTHER FLEX ARM WAS USED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT WAS NOT IMPACTED. THIS REPORT IS FOR ONE (1) FLEX ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911699 ↗
• MalfunctionFeb 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWSIT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE LOCKING MECHANISM OF FLEX ARM FAILED TO LOCK ONTO THE ROD. IT WORKED PREVIOUSLY BUT IS NOW BROKEN. THE KERRISON RONGEURS (DEPUY SPINE PRODUCT) ARE RUSTY AND GET STUCK WHEN IN USE. ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND ANY PATIENT HARM REPORTED.DEPUY SPINE PRODUCTS (KERRISON RONGEURS) ARE REPORTED UNDER RELATED COMPLAINT (B)(4).CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1).THIS REPORT IS FOR ONE (1) FLEX ARM.THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720264 ↗