Zyphr 5100060001Recalls & reported problems

Summary

The FDA's MAUDE database contains 199 adverse event reports that list this exact device (DI 04546540716224), received between Jun 13, 2018 and Sep 3, 2026 — classified as 107 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Failure to Auto Stop” (190 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 16, 2020Terminated

   Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.

   Z-0431-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 199 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Failure to Auto Stop

  It was reported that the perforator malfunctioned while in use, stopping 3-4 times and plunging through dura. The event resulted in unexpected/prolonged care and and a delay in treatment/therapy. No further information available at this point.

  Patient problems: Dural Tear

  MAUDE report 50587752 ↗
• InjuryMay 20, 2026Failure to Auto Stop

  IT WAS REPORTED THAT, DURING SURGERY, THE PERFORATOR DID NOT STOP APPROPRIATELY UPON REACHING THE INNER TABLE OF THE SKULL. IT WENT THROUGH AND PENETRATED THE DURA. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Rupture

  MAUDE report 25234262 ↗
• InjuryMay 20, 2026Failure to Auto Stop

  IT WAS REPORTED THAT, DURING A TREPANATION PROCEDURE, THE DEVICE DID NOT STOP AUTOMATICALLY, RESULTING IN DAMAGE TO THE PATIENT¿S DURA, REQUIRING MEDICAL INTERVENTION. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Rupture

  MAUDE report 25230499 ↗
• InjuryApr 28, 2026Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIOTOMY THE PERFORATOR DID NOT STOP AFTER PENETRATING THE SKULL AND THE DURA WAS PUNCTURED. IT WAS FURTHER REPORTED THAT THE DURA WAS REPAIRED AFTER TUMOR REMOVAL, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Rupture

  MAUDE report 25019630 ↗
• InjuryMar 30, 2026

  THE DISPOSABLE ZYPHR CRANIAL PERFORATOR (LARGE) BY STRYKER DID NOT STOP WHEN APPROPRIATE AND WENT INTO THE PATIENT'S DURA ON THE LEFT SIDE. DURA WAS TORN, BUT WAS REPAIRED DURING SURGERY. IT DID NOT PLUNGE INTO THE BRAIN TISSUE. A NEW PERFORATOR WAS OPENED FOR THE RIGHT SIDE. REF #-5100-060-001, LOT#- 25237057, EXP- 08/01/2028.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710778 ↗
• InjuryFeb 10, 2026Material Disintegration

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WERE FILINGS PRODUCED DUE TO CONTACT WITH A RETRACTOR, WHILE USING THE PERFORATOR BIT. IT WAS ALSO REPORTED THAT THERE WAS EXTENSIVE REMOVAL OF THE CHILD'S TISSUE TO REMOVE THESE FILINGS. NO FURTHER DETAILS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24304749 ↗
• MalfunctionJan 23, 2026Failure to Auto Stop

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FAILURE TO AUTO STOP. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 24163970 ↗
• InjuryDec 18, 2025Failure to Auto Stop; Failure to Auto Stop

  NO NEW INFORMATION.

  Patient problems: Rupture

  MAUDE report 23837486 ↗
• InjuryDec 17, 2025Failure to Auto Stop; Failure to Auto Stop

  NO NEW INFORMATION.

  Patient problems: Rupture

  MAUDE report 23829309 ↗
• InjuryDec 12, 2025Failure to Auto Stop; Failure to Auto Stop

  NO NEW INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 23793548 ↗
• MalfunctionOct 28, 2025Failure to Auto Stop; Failure to Auto Stop

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FAILURE TO AUTO STOP. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399843 ↗
• MalfunctionOct 23, 2025Material Disintegration; Material Disintegration

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: MATERIAL DISINTEGRATION. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368860 ↗
• MalfunctionSep 9, 2025Failure to Auto Stop; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT DID NOT STOP SPINNING AT THE DESIRED TIME, AND PUNCTURED THE DURA. IT WAS ALSO REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Rupture

  MAUDE report 23005049 ↗
• MalfunctionJul 29, 2025Failure to Auto Stop; Failure to Auto Stop

  THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FAILURE TO AUTO STOP. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 22648111 ↗
• InjuryMay 23, 2025Failure to Auto Stop; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT DID NOT STOP SPINNING AT THE DESIRED TIME. IT WAS ALSO REPORTED THAT THERE WAS MEDICAL INTERVENTION REQUIRED TO REPAIR DAMAGED TISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY.

  Patient problems: Rupture

  MAUDE report 22078584 ↗
• InjuryMar 20, 2025Failure to Auto Stop; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT DID NOT STOP SPINNING AT THE DESIRED TIME. IT WAS ALSO REPORTED THAT THERE WAS MEDICAL INTERVENTION REQUIRED TO REPAIR DAMAGED TISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Rupture

  MAUDE report 21654677 ↗
• InjuryMar 20, 2025Failure to Auto Stop; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT DID NOT STOP SPINNING AT THE DESIRED TIME. IT WAS ALSO REPORTED THAT THERE WAS MEDICAL INTERVENTION REQUIRED TO REPAIR DAMAGED TISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Rupture

  MAUDE report 21654628 ↗
• InjuryMar 20, 2025Failure to Auto Stop; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT DID NOT STOP SPINNING AT THE DESIRED TIME. IT WAS ALSO REPORTED THAT THERE WAS MEDICAL INTERVENTION REQUIRED TO REPAIR DAMAGED TISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Rupture

  MAUDE report 21654625 ↗
• InjuryFeb 7, 2025Failure to Auto Stop; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT DID NOT STOP SPINNING AT THE DESIRED TIME. IT WAS ALSO REPORTED THAT A SMALL BLEED REQUIRED COAGULATION. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Rupture

  MAUDE report 21333270 ↗
• MalfunctionJan 21, 2025Failure to Auto Stop; Failure to Auto Stop

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE FAILED TO AUTO-STOP. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 21200838 ↗
• MalfunctionNov 15, 2024Failure to Auto Stop; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT DID NOT STOP SPINNING AT THE DESIRED TIME. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20699012 ↗
• InjuryOct 23, 2024Failure to Auto Stop; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT DID NOT STOP SPINNING AT THE DESIRED TIME. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED A LEFT TEMPORAL CORTICAL WOUND AS A RESULT OF THIS EVENT. ON THE NIGHT FOLLOWING THE INCIDENT, THE PATIENT PRESENTED WITH 2 EPILEPTIC SEIZURES REQUIRING THE INITIATION OF MEDICATION WHICH CANNOT BE ATTRIBUTED WITH CERTAINTY TO THE INCIDENT AS THE PATIENT HAS OTHER CORTICAL LESIONS LINKED TO A MENINGIOMA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THIS REPORT IS FOR THE SECOND DEVICE THAT FAILED TO DISENGAGE.

  Patient problems: Rupture

  MAUDE report 20515304 ↗
• InjuryOct 23, 2024Failure to Auto Stop; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT DID NOT STOP SPINNING AT THE DESIRED TIME REQUIRING A SECOND DEVICE TO BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Rupture

  MAUDE report 20515222 ↗
• MalfunctionOct 21, 2024Failure to Auto Stop; Failure to Auto Stop

  THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS IN WHICH THE DEVICE FAILED TO AUTO-STOP. 9 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 20494496 ↗
• InjuryOct 4, 2024Failure to Auto Stop; Failure to Auto Stop

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE PERFORATOR BIT DID NOT STOP SPINNING AT THE DESIRED TIME. IT WAS ALSO REPORTED THAT THERE WAS MEDICAL INTERVENTION REQUIRED TO REPAIR DAMAGED TISSUE. WE HAVE REQUESTED MORE DETAILS ON THE REPORTED DELAY. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY.

  Patient problems: Rupture

  MAUDE report 20368877 ↗