N/A 9733236Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00613994247865), received between Nov 3, 2017 and Sep 23, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (10 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Dec 4, 2024Open, Classified

   Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.

   Z-1022-2025 · Root cause: Under Investigation by firm · FDA record ↗

2. Nov 28, 2023Open, Classified

   Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.

   Z-0699-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872161 ↗
• InjuryApr 15, 2026Material Fragmentation; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS (PERC) TIP HAD BROKE INSIDE THE PATIENT. IT WAS REPORTED BY THE SITE THAT UPON REMOVAL OF THE PERC PIN, THE SLAP HAMMER WAS CONNECTED TO THE END OF THE PERC PIN TO REMOVE BY THE SCRUB TECH AND ATTEMPTED TO REMOVE. THE SCRUB TECH WAS HAVING DIFFICULTY REMOVING AND APPLIED MORE FORCE TO THE SLAP HAMMER MOTION. AFTER A FEW ATTEMPTS, THE SLAP HAMMER SLIPPED OFF OF THE PERC PIN AND THE SCRUB TECH NOTICED THAT THE RAISED PIN ON THE PERC PIN THAT THE SLAP HAMMER HOOKS AROUND FOR REMOVAL WAS NO LONGER THERE. AT THIS POINT, THE SURGEON GRABBED SOME VICE GRIPS AND ATTACHED TO THE PERC PIN AS HANDLE AND THEN USED A MALLET TO TRY AND PULL THE PERC PIN OUT. WHEN THE PERC PIN FINALLY CAME OUT, THE TIP OF THE PERC PIN REMAINED IN THE PATIENT. THE MEDTRONIC REPRESENTATIVE (REP) ENTERED SHORTLY AFTER AND NOTED THE SURGEON DECIDED TO CONTINUE FINISHING THE PROCEDURE AND FLIPPED THE PATIENT PRONE TO FINISH THE POSTERIOR INSTRUMENTATION, PLACING ANOTHER PERC PIN IN THE RIGHT HIP, NAVIGATING THE HARDWARE AND THEN ATTEMPTED TO RETRIEVE THE TIP OF

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 24887584 ↗
• MalfunctionSep 9, 2025Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN THE SURGEON WAS ATTEMPTING TO GET THE PERC PIN OUT WITH THE SLAP HAMMER, AND PRYING IT OUT, A PIECE OF THE PERC PIN BROKE OFF INTO THE PATIENT. A MANUFACTURER REPRESENTATIVE (REP) REPORTED THEY DID NOT KNOW IF THE SURGEON WAS ABLE TO GET THE PIN OUT AS THE CASE WAS STILL GOING. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME REPORTED. ADDITIONAL INFORMATION WAS RECEIVED; THE SURGEON DID REMOVE THE PIN BUT LEFT THE TIP (PIECE THAT BROKE) IN THE PATIENT. IT WAS CONFIRMED THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008213 ↗
• MalfunctionJun 20, 2025Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERC PIN BROKE INSIDE OF THE PATIENT WHEN REMOVING IT FROM THE PATIENT. THE SITE WAS USING A VICE GRIP TO REMOVE. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301271 ↗
• MalfunctionSep 4, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PERC PIN WAS NOT FITTING INTO THE REFERENCE FRAME AS THE DIAMETER WAS TOO LARGE. OPENED 3 MORE UNTIL ONE OF THEM FIT INTO THE FRAME. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134127 ↗
• MalfunctionAug 26, 2024Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THE PATIENT WEIGHT WAS ASKED FOR BUT IS UNKNOWN. THERE WAS A QUANTITY OF ONLY 1 INSTRUMENT INVOLVED IN THIS EVENT. THIS INFORMATION WAS CONFIRMED TO BE TRUE WITH THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064924 ↗
• MalfunctionAug 21, 2024Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PIECE THAT THE SLAP HAMMER CONNECTS TO BROKE OFF WHEN TRYING TO GET THE PERCUTANEOUS PIN OUT AND IT WAS NOT ABLE TO BE REMOVED. THE ORTHOPEDIC SURGEON WAS CALLED IN HELP WITH REMOVAL. AFTER SEVERAL MINUTES AND ATTEMPTS, THEY WERE ABLE TO REMOVE THE PIN WITH NO HARM TO THE PATIENT. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20021384 ↗
• MalfunctionMay 17, 2024Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE IN USE IN THE PATIENT. NO KNOWN IMPACT TO PATIENT OUTCOME. SURGICAL DELAY UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340847 ↗
• MalfunctionJan 8, 2024Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SLAP HAMMER TO REMOVE THE 150MM PERC PIN FROM THE PATIENT, ON THE SECOND PASS, THE LITTLE PIN THAT HELD BOTH THE SLAP HAMMER AND NAVIGATION FRAME IN PLACE SHEARED OFF INSIDE THE SLAP HAMMER. THAT PIECE WAS REMOVED FROM THE SLAP HAMMER AND PASSED OFF THE STERILE FIELD. IN ORDER TO REMOVE THE PERC PIN FROM THE PATIENT, A DRILL CHUCK WAS ATTACHED TO THE TOP OF THE PERC PIN AND THEN A SLOW POWERED DRILL WAS USED TO BACK THE PERC PIN OUT OF THE PATIENT'S BONE. WHEN THE PERC PIN WAS FULLY REMOVED FROM THE PATIENT AND INSPECTED, THE SURGEON SAW THAT THE PORTION OF THE PERC PIN THAT ENTERED THE BONE WAS SHEARED OFF AS WELL AND WAS THEN CONFIRMED BY X-RAY. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464812 ↗
• MalfunctionJan 3, 2024Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE POST OF THE PERC PIN SHEARED OFF WHEN THEY WERE USING THE SLAP HAMMER TO TRY TO GET IT OUT OF THE BONE. IT WAS REPORTED THAT IT WAS VERY HARD TO GET PERC PIN IN BECAUSE OF HARDNESS OF BONE. THE SURGEON SWITCHED TO PLIERS ONCE THE POST HAD SHEARED OFF. THE PERC PIN BROKE AND APPROXIMATELY HALF AN INCH WAS STILL IN THE PATIENT BONE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435196 ↗
• MalfunctionNov 27, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERC PIN TAB WAS TOO LARGE TO FIT IN THE TAP CAP. THEY OPENED A SECOND INSTRUMENT TRAY TO TRY ANOTHER TAP CAP AND THE PERC PIN DID NOT FIT IN THAT ONE EITHER. THE SPINE REP WENT TO SEE IF ANOTHER PERC PIN WAS AVAILABLE TO USE. NO PATIENT IMPACT. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211323 ↗
• MalfunctionNov 22, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO PLACE A SMALL PERC PIN AND LARGE PERC PIN TO ANCHOR THE REFERENCE FRAME, THE SMALL PERC PIN WOULD NOT FIT ONTO THE TAP CAP. THE SMALL PIN WAS NOT USED. THE LARGE PIN FIT BETTER WITH THE CAP. AFTER USE, THE CAP WOULD NOT COME OFF OF THE LARGE PIN. THE USE OF MEDTRONIC IMAGING WAS ABORTED, BUT THEY CONTINUED WITH NAVIGATION. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194805 ↗
• MalfunctionNov 22, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO PLACE A SMALL PERC PIN AND LARGE PERC PIN TO ANCHOR THE REFERENCE FRAME, THE SMALL PERC PIN WOULD NOT FIT ONTO THE TAP CAP. THE SMALL PIN WAS NOT USED. THE LARGE PIN FIT BETTER WITH THE CAP. AFTER USE, THE CAP WOULD NOT COME OFF OF THE LARGE PIN. THE USE OF MEDTRONIC IMAGING WAS ABORTED, BUT THEY CONTINUED WITH NAVIGATION. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194692 ↗
• MalfunctionNov 22, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO PLACE A SMALL PERC PIN AND LARGE PERC PIN TO ANCHOR THE REFERENCE FRAME, THE SMALL PERC PIN WOULD NOT FIT ONTO THE TAP CAP. THE SMALL PIN WAS NOT USED. THE LARGE PIN FIT BETTER WITH THE CAP. AFTER USE, THE CAP WOULD NOT COME OFF OF THE LARGE PIN. THE USE OF MEDTRONIC IMAGING WAS ABORTED, BUT THEY CONTINUED WITH NAVIGATION. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194596 ↗
• MalfunctionOct 17, 2023Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT AFTER A PROCEDURE, THE SURGEON WAS ATTEMPTING TO REMOVE THE PERC PIN AND ABOUT 1CM OF THE TIP BROKE OFF AND REMAINED IN THE PATIENT. THE SURGEON TRIED TO REMOVE THE PERC PIN USING THE SLAP HAMMER, BUT THE TAB ON THE PERC PIN BROKE OFF. HE THEN HAD TO USE A CLAMP AND MALLET TO TRY TO GET IT OUT AND THAT IS WHEN THE PERC PIN BROKE. THE MEDTRONIC REPRESENTATIVE (REP) NOTED THAT THE PERC PIN WAS PLACED PRETTY DEEP SINCE THE PATIENT WAS LARGER. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 5 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949253 ↗
• MalfunctionMay 24, 2023Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE "SECURITY" PIN ON THE PERC PIN BROKE OFF DURING SLAPHAMMER INSTRUMENT REMOVAL. THE SITE HAD TO USE VICE GRIPS TO FULLY REMOVE THE PERC PIN. THE SITE FOUND THE BROKE PIECE OF THE PERC PIN. THERE WAS A SURGICAL DELAY OF LESS THAN TEN MINUTES. NO KNOWN IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991735 ↗
• MalfunctionMar 20, 2023Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SMALL SET PIN BROKE OFF. THE SLAP BACK HAMMER WAS NOT ABOUT TO BE USED TO REMOVE THE PIN FROM THE PATIENT. THE SURGEON HAD TO USE AN ALTERNATE METHOD. ADDITIONAL INFORMATION WAS RECEIVED. THE SMALL SET PIN BROKE OFF INSIDE THE PATIENT TEMPORARILY, AND WAS REMOVED BY THE SURGEON BY ATTACHING TO A POWER DRILL FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573631 ↗
• MalfunctionMar 9, 2023Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT WHEN THE DISPOSABLE WAS OPENED, THE SITE REALIZED THAT THE WHITE SILICON CYLINDER THAT IS ON THE TOP PART WAS MISSING, WHICH MADE IT IMPOSSIBLE TO PROPERLY FIX THE PATIENT REFERENCE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515909 ↗
• MalfunctionSep 8, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT WHEN THE SURGEON WAS REMOVING THE SLAP HAMMER, THE PERC PIN BROKE OFF. THE SURGEON WAS ABLE TO REMOVE THE PIECE FROM THE PATIENT'S ANATOMY. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378099 ↗
• MalfunctionJun 16, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRAOPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT AT THE END OF THE PROCEDURE WHEN USING THE SLAP HAMMER TO REMOVE THE PERCUTANEOUS PIN, THE SLAP HAMMER SHEARED OFF THE PIECE OF THE PIN THAT ADHERES TO THE SLAP HAMMER. VICE GRIPS WERE USED TO THEN HAMMER OUT THE PIN. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712334 ↗
• InjuryMar 2, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT, WHILE MALLETING THE PERC PIN AND IT BROKEN WHILE STILL INSIDE THE PATIENT. THERE WAS A LESS THAN 1-HOUR DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME. THE LIKELY CAUSE OF THE ISSUE WAS THE PERC PIN BEING HAMMERED INTO A PREVIOUSLY APPLIED HARDWARE. THE SURGEON DECIDED TO LEAVE THE BROKEN PIECE INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 11401565 ↗
• InjuryAug 27, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A OBLIQUE LUMBAR INTERBODY FUSION (OLIF) PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN WAS PLACED AND UPON ATTEMPTING TO CONNECT THE REFERENCE FRAME, THE LOCKING PIN FELL OUT OF THE PIN, CAUSING A REMOVAL OF THE PIN AND RE-INSERTION OF A NEW PIN. THERE WAS NO DELAY IN THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8935403 ↗
• MalfunctionMar 8, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN WOULD NOT FIT INTO THE PERCUTANEOUS REFERENCE FRAME. THE END USER TRIED STERILE MINERAL OIL TO LUBRICATE THE POST BUT HAD NO SUCCESS. A SECOND PERCUTANEOUS PIN WAS TRIED WITHOUT SUCCESS. THE PIN WAS WEDGED INTO THE POST OF THE PERCUTANEOUS FRAME; NO MOVEMENT OF PIN TO FRAME WAS SEEN AND THE SURGEON MOVED FORWARD WITH THE PROCEDURE. NAVIGATION WAS NOT DISCONTINUED, AND MEDTRONIC IMAGING WAS USED AND COMPLETED WITHOUT INCIDENT. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR DUE TO THIS ISSUE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS SUSPECTED THERE WAS DAMAGE TO THE REFERENCE FRAME WHEN TWO PERCUTANEOUS PINS OF DIFFERENT LOTS WOULD NOT FIT. THE SITE ORDERED AND RECEIVED A NEW FRAME AT A LATER DATE. AT THIS TIME A MEDTRONIC REPRESENTATIVE (REP) TRIED THE PERCUTANEOUS PINS SAVED FROM THE INCIDENT. THE SAME ISSUE OCCURRED WITH BOTH PERCUTANEOUS PINS. UPON ADVICE FROM TECHNICAL SERVICES (TS), A NEW PERCUTANEOUS PIN WAS OPENED FROM THE SHELF AND IT WOULD SUCCESSFULLY FIT INTO THE NEW FRAME BUT NOT THE OLD FRAME. IT WAS NO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406317 ↗
• MalfunctionAug 24, 2018Failure to Align; Failure to Align

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE AIRFRAME DID NOT SIT FLUSH ON THE PERC PIN, BUT INSTEAD ROTATED SLIGHTLY ON THE PIN, CONNECTIONS WERE CONFIRMED TO BE TIGHT AND SECURE. IN AN ATTEMPT TO RESOLVE THE ISSUE THE MANUFACTURER REPRESENTATIVE SWITCHED OUT DIFFERENT PERC PINS (SHORT AND LONG) AND 3 DIFFERENT AIRFRAMES, WHICH DID NOT RESOLVE THE ISSUE. POTENTIAL DELAY TO PROCEDURE AND PATIENT IMPACT ARE UNKNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7813131 ↗
• MalfunctionDec 18, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT AFTER A SPINAL FUSION PROCEDURE, THE SURGEON WAS REMOVING A PERC PIN AND BENT THE INSTRUMENT. IT WAS REPORTED THAT THE SURGEON WAS REMOVING THE PIN BY GRABBING THE REFERENCE FRAME AND PULING ON IT. IN THE PROCESS, SURGEON BROKE THE PIN ON THE PERC PIN WHICH MADE USING A SLAP HAMMER IMPOSSIBLE. SURGEON THE USED PLIERS TO REMOVE THE PERC PIN. THE PER PIN WAS REMOVED SUCCESSFULLY WITHOUT ANY PATIENT HARM BUT THE INSTRUMENT WAS BENT. MEDTRONIC REPRESENTATIVE INFORMED SURGEON NOT TO REMOVE THE PERC PIN IN THE PROCESS AND USE OF SLAP HAMMER. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125848 ↗