LUPINE 211042Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886705001545), received between May 31, 2018 and Jun 10, 2024 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE LUPINE SPIRAL FLUTED DRILL BIT DEVICE BROKE INSIDE THE HUMERUS OF THE PATIENT WHILE PERFORMING A BICEPS TENODESIS. ACCORDING TO THE REPORTER, IT WAS NOT NOTICED UNTIL AFTER ANCHOR IMPLANTATION AND THE DRILL BIT WAS CONTAINED IN THE BONE AND THE SURGERY WAS COMPLETED. THE DOCTOR FELT NO NEED TO RETRIEVE THE BROKEN DRILL BIT AS IT SEEMED TO NOT BE AN URGENT MATTER THAT COULD LEAD TO EFFECTS LONGTERM. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19498108 ↗
• MalfunctionAug 4, 2023Degraded; Degraded

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE LUPINE - SPIRAL FLUTED DRILL BIT DEVICE WAS DULL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459852 ↗
• MalfunctionFeb 24, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE TIP ON THE LUPINE SPIRAL FLUTED DRILL BIT DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13593766 ↗
• InjuryFeb 10, 2020Break; Entrapment of Device; Material Twisted/Bent; Break; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT THE LUPINE SPIRAL FLUTED DRILL BIT NEEDS TO BE REPLACE, BECAUSE THE SURGEON BELIEVES HE CAN SEE METAL SHARDS IN A POST OP IMAGING AND WANTS THE UNIT TO BE REPLACED. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9688760 ↗
• InjuryFeb 5, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT THE LUPINE SPIRAL FLUTED DRILL BIT NEEDS TO BE REPLACE, BECAUSE THE SURGEON BELIEVES HE CAN SEE METAL SHARDS IN A POST OP IMAGING AND WANTS THE UNIT TO BE REPLACED. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9673505 ↗
• InjuryOct 30, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY THE SALES REP THAT THE LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS COULD NOT BE USED DUE TO THE FAILURE OF THE LUPINE - SPIRAL FLUTED DRILL BIT WHICH WAS CAUSING METAL SHAVINGS IN THE PROCEDURE AND THEY WERE SUCCESSFULLY REMOVED. THE CASE WAS COMPLETED WITH NEW DRILL BIT AND DRILL HOLE, NEW LUPINE. NO PATIENT CONSEQUENCES NOR SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Injury; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9256866 ↗
• MalfunctionJun 21, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A LABRAL STABILIZATION THE LUPINE SPIRAL FLUTED DRILL BIT WAS BLUNT. THE SURGERY WAS CONTINUED. THERE WAS NIL IMPACT TO THE PATIENT. ADDITIONAL INFORMATION REPORTED BY THE AFFILIATE STATED THERE WAS A ANOTHER DRILL BIT THAT WAS AVAILABLE OFF OF ANOTHER SET. THERE WAS SURGICAL DELAY OF 2 MINUTES TO OPEN THE OTHER TRAY.

  Patient problems: Not Applicable

  MAUDE report 8722648 ↗
• MalfunctionMay 29, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE TWO OF THE CUSTOMER'S LUPINE SPIRAL FLUTED DRILL BITS AND TWO OF THE CUSTOMER'S GRYPHON DRILL BITS WERE DULL. THE CASE WAS COMPLETED WITH ONE OF THE FOUR DEVICES, BUT THE SALES REP DID NOT KNOW WHICH ONE. THERE WAS NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE THE LOT NUMBERS OF THE DEVICES OR ANY ADDITIONAL INFORMATION. THE DEVICES ARE BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION PROVIDED BY THE SALES REP REPORTED THAT THERE WERE 6-DRILL BITS(SHARP) INSTEAD OF THE 4-DRILL BITS INITIALLY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8651149 ↗
• MalfunctionMay 6, 2019Dull, Blunt; Dull, Blunt

  THIS IS REPORT 2 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE TWO OF THE CUSTOMER'S LUPINE SPIRAL FLUTED DRILL BITS AND TWO OF THE CUSTOMER'S GRYPHON DRILL BITS WERE DULL. THE CASE WAS COMPLETED WITH ONE OF THE FOUR DEVICES, BUT THE SALES REP DID NOT KNOW WHICH ONE. THERE WAS NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE THE LOT NUMBERS OF THE DEVICES OR ANY ADDITIONAL INFORMATION. THE DEVICES ARE BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583450 ↗
• MalfunctionMay 6, 2019Dull, Blunt; Dull, Blunt

  THIS IS REPORT 1 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE TWO OF THE CUSTOMER'S LUPINE SPIRAL FLUTED DRILL BITS AND TWO OF THE CUSTOMER'S GRYPHON DRILL BITS WERE DULL. THE CASE WAS COMPLETED WITH ONE OF THE FOUR DEVICES, BUT THE SALES REP DID NOT KNOW WHICH ONE. THERE WAS NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE THE LOT NUMBERS OF THE DEVICES OR ANY ADDITIONAL INFORMATION. THE DEVICES ARE BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583443 ↗
• MalfunctionMay 6, 2019Dull, Blunt; Dull, Blunt

  THIS IS REPORT 4 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING INSPECTION OF THE DEVICES, IT WAS IDENTIFIED THAT TWO OF THE CUSTOMER'S LUPINE SPIRAL FLUTED DRILL BITS AND TWO OF THE CUSTOMER'S GRYPHON DRILL BITS WERE DULL. THERE WAS NO PATIENT INVOLVEMENT. THE LOT NUMBERS ARE UNKNOWN. TWO DEVICES ARE BEING RETURNED FOR EVALUATION AND THE OTHER TWO WERE DISCARDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8583109 ↗
• MalfunctionMay 6, 2019Dull, Blunt; Dull, Blunt

  THIS IS REPORT 3 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING INSPECTION OF THE DEVICES, IT WAS IDENTIFIED THAT TWO OF THE CUSTOMER'S LUPINE SPIRAL FLUTED DRILL BITS AND TWO OF THE CUSTOMER'S GRYPHON DRILL BITS WERE DULL. THERE WAS NO PATIENT INVOLVEMENT. THE LOT NUMBERS ARE UNKNOWN. TWO DEVICES ARE BEING RETURNED FOR EVALUATION AND THE OTHER TWO WERE DISCARDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8583103 ↗
• MalfunctionFeb 4, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A BICEP REPAIR PROCEDURE THE CUSTOMER'S LUPINE SPIRAL FLUTED DRILL BIT TIP BROKE OFF INSIDE THE PATIENT. THE SALES REP DID NOT KNOW HOW THE DEVICE BROKE, AND STATED THAT THE TIP OF THE DEVICE WAS SUCCESSFULLY REMOVED, BUT DID NOT KNOW HOW IT WAS REMOVED. THE SALES REP DID NOT KNOW THE BONE QUALITY OF THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER DRILL BIT WITH NO PATIENT HARM OR DELAY. THE SALES REP STATED THAT THERE IS NO NEED FOR FUTURE SURGICAL INTERVENTION. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE. THE AVAILABILITY OF THE DEVICE IS UNKNOWN. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301440 ↗
• MalfunctionOct 9, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S LUPINE SPIRAL FLUTED DRILL BIT WAS DULL THE SALES REP STATED THAT IT IS DULL AS A RESULT OF USE OVER TIME RATHER THAN BECOMING DULL DURING THIS CASE. THE SALES REP STATED THE PATIENT'S BONE QUALITY WAS NORMAL. THE CUSTOMER'S LUPINE STABILIZATION SAWTOOTH DRILL GUIDE TIP WAS BENT AND LED TO DIFFICULTIES MOVING THE LUPINE DRILL BIT THROUGH. THE SALES REP DID NOT KNOW HOW THE DEVICE BECAME BENT. THE CASE WAS COMPLETED WITH THESE DEVICES WITH NO PATIENT HARM OR DELAYS. THE SALES REP WAS UNABLE TO PROVIDE LOT NUMBERS FOR THESE DEVICES. THE DEVICES WERE DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948779 ↗
• MalfunctionMay 31, 2018Dull, Blunt; Dull, Blunt

  THE SALES REP REPORTED VIA PHONE THAT THE CUSTOMER'S LUPINE SPIRAL FLUTED DRILL BIT WAS DULL DURING A SHOULDER REPAIR. THE CASE WAS COMPLETED WITH THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED. UPDATE RECEIVED FROM THE SALES REP ON 1-8-2018: THE DEVICE IS NOT GOING TO BE RETURNED, IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556417 ↗