Medtronic Reusable Instruments 873-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00673978067704), received between Dec 16, 2020 and Nov 24, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MAGERL'S TECHNI QUE BY ATLANTOAXIAL SUBLUXATION. IT WAS REPORTED THAT WHEN A DRILL WAS USED TO CREATE A UCSS PILOT HOLE, THE DRILL BROKE FROM THE ROOT INSIDE THE BONE. THE GUIDEWIRE CAN BE REMOVED TOGETHER WITH THE DEVICE. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204263 ↗
• MalfunctionJun 17, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR SPINAL SURGERY. PRE-OPERATIVE DIAGNOSIS WAS RETRO-ODONTOID PSEUDOTUMOR. PROCEDURE PERFORMED IN THE EVENT WAS MAGERL METHOD. LEVEL AT WHICH THE IMPLANT PERFORMED WAS C1-2. IT WAS REPORTED THAT INTRA-OPERATIVELY, WHEN PASSING THROUGH THE ATLANTOAXIAL JOINT, THE THREAD OF THE DRILL BROKE FROM THE CUT ROOT. THE INSTRUMENT CAME IN CONTACT WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14729106 ↗
• MalfunctionNov 26, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A DRILL BIT DURING A CERVICAL POSTERIOR FUSION FOR A CERVICAL SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE PRODUCT WAS BROKEN WHEN IT WAS ATTACHED TO A POWER TOOL AND CREATING A PILOT HOLE. THE DRILL BROKE IN THE BONE, SO IT REMAINED IN THE BONE BUT HAS BEEN REMOVED. THE EVENT WAS ASSOCIATED WITH A PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY IN OVERALL PROCEDURE OF OVER 60 MINUTES. THIS PROCEDURE WAS NOT A REVISION SURGERY, THERE WAS NO IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION NECESSARY, AND THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12877070 ↗
• MalfunctionAug 18, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334924 ↗
• MalfunctionFeb 15, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT SPINAL THERAPY FOR ODONTOID PROCESS FRACTURE. IT WAS REPORTED THAT WHILE DRILLING THE BONE THE INSTRUMENT BROKEN INSIDE THE PATIENT (ALL SERRATED PART WAS INSIDE THE PATIENT) THEN HE USED RONGEUR TO GET THE BROKEN PART OUT. THERAPY INVOLVED IN THE EVENT WAS ODONTOID PROCESS FRACTURE THE SAME PROCEDURE PROVIDED IN ST. THERE WERE SOME FRAGMENTS LEFT INSIDE THE PATIENT. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327048 ↗
• MalfunctionJan 11, 2021Break; Break

  INFORMATION WAS REPORTED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A DRILL BIT FOR A MAGAL METHOD. IT WAS REPORTED THAT THE PILOT HOLE CREATION WAS PLANNED AT C1-2 WITH MAGAL METHOD. AFTER THE PILOT HOLE WAS CREATED WITH DRILL BIT, THE DRILL WAS REMOVED. AT THAT TIME, THE DRILL OF THE TIP OF DRILL BIT WAS NOTED TO BE BROKEN. IT WAS UNKNOWN WHEN DID THE BREAKAGE OCCUR. THERE WAS NO PROBLEM WITH CREATING THE PILOT HOLE. SINCE THE BROKEN PART OF THE DRILL WAS ABOVE THE BONE SURFACE, THE DRILL WAS TURNED WITH PLIERS AND REMOVED. AFTER THAT, THE OPERATION WAS COMPLETED WITHOUT PROBLEMS. THE DRILL BIT WAS FRACTURED UNINTENTIONALLY DURING USE. THE INSTRUMENT BROKE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THERE WAS A POSSIBILITY THAT THE INSTRUMENT WAS BENT BECAUSE THE DRILL GUIDE WAS TILTED TO THE CAUDAL SIDE. IT WAS CONSIDERED POSSIBLE THAT THE PRODUCT WAS BROKEN DUE TO BENDING AND DETERIORATION OVER TIME. THE EVENT WAS ASSOCIATED WITH A PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CAME IN CONTACT WITH THE REPORTED PROD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146042 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF AT LANTOAXIAL SUBLUXATION, UNDERGOING A FUSION PROCEDURE. IT WAS REPORTED THAT C1/2 FUSION USING INFINITY WAS SCHEDULED FROM BEGINNING, BUT THE NAVIGATION WAS DOWN, IT WAS JUDGED DIFFICULT TO IMPLEMENT, SO IT WAS DECIDED TO USE MAGERL METHOD USING UCSS. ON THE LEFT SIDE OF THE FIRST PROCEDURE, HEAVY BLEEDING OCCURRED WHEN DRILLING WITH THE REPORTED PRODUCT. IT WAS JUDGED THAT THE VA WAS DAMAGED, AND THE OTHER SIDE WAS GIVEN UP. MCGRAW METHOD WAS PERFORMED ADDITIONALLY AND THE OPERATION WAS COMPLETED. THERE WAS A DELAY OF LESS THAN 60 MINS. INITIAL REPORTER INFORMATION CANNOT BE PROVIDED DUE TO THE RESTRICTION BY THE PRIVACY REGULATION. THE PRODUCT WILL BE RETURNED AND WILL NOT BE REPLACED. ADDITIONAL INFO RECEIVED. IT WAS REPORTED THAT, AFTER BLEEDING, COMPRESSION HEMOSTASIS WAS PERFORMED. THE AMOUNT OF BLEEDING IS UNKNOWN. CT IMAGING WAS PERFORMED AFTER THE OPERATION, AND IT WAS CONFIRMED THAT VA WAS OKAY. DOCTORS RECOGNIZE THAT THE DRILL ITSELF IS NOT DEFECTIVE/NO MALFUNCTION AND IT'S A TECHNICAL FACTOR. THE PATIENT ISSUE WAS RESOLVED. PATIENT: (B)(6);

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11018359 ↗