NA 389.41Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034775623), received between Jan 8, 2020 and Apr 23, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS INSTANCES OF 2 KERRISON WITH WELD FAILURE IN THE PINS THAT HOLD THE HANDLE TOGETHER. 1 KERRISON THAT STICKS WHEN SQUEEZING THE HANDLE AND A VERTEBRAL BODY SPREADER THAT IS MISSING A PIN RETURNING FROM THE FIELD. THESE WERE NOT REPORTED AS HAVING BEEN USED IN ANY SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION FROM THE FIELD IN WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889821 ↗
• MalfunctionApr 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS INSTANCES OF 2 KERRISON WITH WELD FAILURE IN THE PINS THAT HOLD THE HANDLE TOGETHER. 1 KERRISON THAT STICKS WHEN SQUEEZING THE HANDLE AND A VERTEBRAL BODY SPREADER THAT IS MISSING A PIN RETURNING FROM THE FIELD. THESE WERE NOT REPORTED AS HAVING BEEN USED IN ANY SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION FROM THE FIELD IN WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883504 ↗
• MalfunctionJan 29, 2024Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A PROCEDURE, THE SCREW FELL OUT OF THE INSTRUMENT IN QUESTION. DURING THIS TIME, THE UPPER AND LOWER SHAFTS AND THE HANDLE SEPARATED. ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/330MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597492 ↗
• MalfunctionDec 13, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREW IN QUESTION CAME LOOSE FROM THE KERRISON WHILE IN USE BY THE SURGEON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/330MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320022 ↗
• MalfunctionSep 6, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THE EVENT WAS POSTOPERATIVE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692949 ↗
• MalfunctionMay 23, 2023Use of Device Problem; Compatibility Problem; Material Integrity Problem; Use of Device Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON APR 4, 2023, THE DISTRIBUTOR FOR THE SURGEON LISTED RECEIVED AN INSTRUMENT SET AND THE 4MM RONGEUR WAS BROKEN AT THE HANDLE BECAUSE IT WAS MISSING THE LEVER PIECE THAT ALLOWS THE HANDLES TO ARTICULATE. THIS DID NOT ALLOW THE INSTRUMENT TO FUNCTION AS INTENDED, SO IT WAS NOT USED DURING THE CASE. OTHER INSTRUMENTS WERE USED TO SUCCESSFULLY COMPLETE THE CASE. NO PATIENT INJURY OR HARM WAS INDICATED. THE SPREADER IN THEIR POSSESSION WAS LATER IDENTIFIED TO BE BROKEN AS WELL BECAUSE IT WOULD NOT RATCHET AS INTENDED DUE TO SPRING DAMAGE IN THE HANDLE COMPONENT. THIS REPORT IS FOR ONE (1) 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/330MM LENGTH. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986048 ↗
• MalfunctionOct 14, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A SCREW HOLDING THE KERRISON TOGETHER CAME LOOSE AND THE INSTRUMENT FELL APART WHILE THE SURGEON WAS PERFORMING DISCECTOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT HARM. THIS REPORT INVOLVES ONE (1) 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/330MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631626 ↗
• InjuryJan 8, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SCREW PIECE OF THE LAMINECTOMY PUNCH THAT CONNECTS THE HANDLE CAME LOOSE DURING SURGERY AND FELL INTO THE PATIENT. IT WAS NOT IDENTIFIED UNTIL AFTER THE IMPLANTS WERE SECURED. SURGEONS AGREED THAT IT WAS BETTER LEFT IN THE PATIENT, WHICH RESULTED IN AN INTENTIONAL RETAINED FOREIGN OBJECT. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN IMPLANTS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/ 330MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9566099 ↗