Medtronic Reusable Instruments 2900163Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885074038308), received between Sep 29, 2020 and Aug 13, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232373 ↗
• MalfunctionJun 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SPINAL THERA PY. IT WAS REPORTED THAT THE RING CURETTE TIP BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182232 ↗
• MalfunctionMay 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN TRANSFORAMINAL LUMBAR INTER BODY FUSION THERAPY FOR DISC SPACE. IT WAS REPORTED THAT THE INSTRUMENT BREAKAGE OCCURRED INVOLVING A 10MM RING CURETTE, WHICH WAS FOUND TO HAVE A CRACK AT THE TIP AND WAS OVERLAPPING BEFORE THE PATIENT WAS IN THE ROOM. THE SCRUB NOTICED THE ISSUE WHEN REMOVING IT FROM THE SET, AND IT REMAINED INTACT DESPITE THE CRACK THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE DEVICE DAMAGED IN THE RE-USE NOT IN THE FIRST TIME USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979107 ↗
• MalfunctionApr 23, 2025Crack; Crack

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A CURETTE AND PROBE HAVING SPI NAL THERAPY. IT WAS REPORTED THAT THERE WAS WITH A CRACK IN THE TIP OF THE CURETTE IN SPD AFTER A CASE. PROBE WAS FOUND BENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889715 ↗
• MalfunctionJan 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-S1 PLIF FOR AN INDICATION OF L4-S1 DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE RING CURETTE WAS SNAPPED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136479 ↗
• MalfunctionMay 16, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT, WHILE DOING THE DISC PREP ON THE L4/5 LEVEL FOR OUR FIRST TLIF, SURGEON WAS USING THE UTERINE CURETTE, HEARD A SNAP. THE INSTRUMENT WAS PULLED OUT, BUT THE BROKEN TIP WAS LEFT INSIDE THE PATIENT. SURGEON TRIED TO FIND THE BROKEN OFF ITEM FOR A FEW SECONDS, BUT COULDN'T. THE X-RAY SHOWED US EXACTLY WHERE THE ITEM WAS, SO THE SURGEON WAS ABLE TO REMOVE THE BROKEN INSTRUMENT'S TIP FROM THE PATIENT. THEN, IT WAS CONTINUED TO DO DISC PREPARATION, JUST WITH THE OTHER INSTRUMENTS THAT WAS AVAILABLE FOR THE CASE. THERE WAS A DELAY OF 5 MINUTES REPORTED. THE CATALYFT CAGE WAS IMPLANTED AT THE LEVEL WHERE THE INCIDENT HAPPENED. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19338217 ↗
• MalfunctionJun 16, 2021Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR DISCET OMY AT THE L3-4, L4-5 LEVELS. PRE-OPERATIVE DIAGNOSIS : L3-5 LUMBAR STENOSIS IT WAS REPORTED THAT DOCTOR WAS PERFORMING A DISCECTOMY AT THE L3-4, L4-5 LEVELS AND PREPPING TO IMPLANT A CAPSTONE DEVICE. UPON USING THE UTERINE CURETTE, HE WAS SCRAPPING THE ENDPLATES WITH THE INSTRUMENT AND FELT IT BREAK LOOSE. HE REMOVED THE INSTRUMENT AND NOTICED A CRACK ON ONE SIDE OF THE CURETTE. HE IMMEDIATELY PLACED IT OFF THE STERILE FIELD. NO FRAGMENT WAS LEFT INSIDE THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT. UPDATE : THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12006594 ↗
• MalfunctionDec 22, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH UNKNOWN INDICATION FOR LUMBAR FUSION (TLIF). IT WAS REPORTED THAT THE RING PORTION OF CURETTE BROKE OFF. BOTH BROKEN PARTS WILL BE RETURNED. PATIENT INVOLVED IN THIS EVENT. BUT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. PRE-OP DIAGNOSIS WAS MYELOPATHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11053599 ↗
• MalfunctionNov 25, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH STENOSIS FOR PLIF. IT WAS REPORTED THAT INTRA-OPERATIVELY, RING CURETTE WAS BROKEN. THERE WAS NO FRAGMENTS OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THE PRODUCT CAME IN CONTACT WITH PATIENT BUT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10902861 ↗
• MalfunctionNov 23, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH AN INDICATION OF DEGENERATIVE SPINE. IT WAS REPORTED THAT DURING INTRA-OP OF PLIF PROCEDURE DEVICE BROKEN. NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT. THERE WAS NO DELAY IN SURGERY. THE INSTRUMENT WAS IN USE WHEN IT BROKEN SO IT DID COME INTO CONTACT WITH THE PATIENT. PRODUCT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10884368 ↗
• InjurySep 29, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) DUE TO L5-S1 SPINAL STENOSIS. IT WAS REPORTED THAT RING CURETTE BROKE IN THE DISC SPACE AND COULD NOT BE RETRIEVED BY THE PHYSICIAN. FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THE PRODUCT WILL BE RETURNED AND REPLACED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10598942 ↗