NA 211033Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886705001453), received between Jun 27, 2018 and Jul 31, 2025 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Break” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY LABRAL REPAIR SURGICAL PROCEDURE, WHEN USING THE LUPINE STABILIZATION DRBT GUIDE DEVICE IT WAS OBSERVED THAT THERE WERE METAL SHAVINGS THAT CAME OFF THE DEVICE INTO THE JOINT. IT WAS REPORTED THAT THE SHAVINGS WERE REMOVED USING THE SHAVER/SUCTION DEVICE. IT WAS REPORTED THAT A DIFFERENT LUPINE DRILL BIT AND GUIDE WERE USED TO IMPLANT REMAINING ANCHORS. IT WAS REPORTED THAT THERE WAS A 15 MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674265 ↗
• MalfunctionAug 26, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY LABRAL REPAIR PROCEDURE, A FISHMOUTH DRILL GUIDE DURABLE DRILL GUIDE DEVICE AND A STABILIZATION DRILL BIT DURABLE DEVICE DESIGNED FOR DRILLING 2.9MM DRILL HOLE DEVICE WERE USED TOGETHER. ACCORDING TO THE REPORT, THERE WERE METAL SHAVINGS THAT CAME OFF INTO THE JOINT DURING USE. IT WAS REPORTED THAT THE SHAVINGS WERE REMOVED VIA SHAVER/SUCTION. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064766 ↗
• MalfunctionAug 26, 2024Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY LABRAL REPAIR PROCEDURE, A FISHMOUTH DRILL GUIDE DURABLE DRILL GUIDE DEVICE AND A STABILIZATION DRILL BIT DURABLE DEVICE DESIGNED FOR DRILLING 2.9MM DRILL HOLE DEVICE WERE USED TOGETHER. ACCORDING TO THE REPORT, THERE WERE METAL SHAVINGS THAT CAME OFF INTO THE JOINT DURING USE. IT WAS REPORTED THAT THE SHAVINGS WERE REMOVED VIA SHAVER/SUCTION. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064711 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY LABRAL REPAIR PROCEDURE THE LUPINE STABILIZATION DRBT DEVICE CAME OFF INTO THE JOINT. THE SHAVINGS WERE REMOVED VIA SHAVER/SUCTION. A DIFFERENT LUPINE DRILL BIT WAS USED TO IMPLANT REMAINING ANCHORS. NO PATIENT HARM OCCURRED, THERE WAS A 15MIN DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511268 ↗
• MalfunctionMay 3, 2024Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ARTHROSCOPY LABRAL REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE LUPINE STABILIZATION DRBT DEVICE WAS HAVING A DIFFICULT TIME DRILLING INTO THE GLENOID. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DRILL BIT SEEMED DULL AND WOULD NOT EFFECTIVELY DRILL INTO THE GLENOID. THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239384 ↗
• MalfunctionFeb 19, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING SHOULDER ARTHROSCOPY LABRAL REPAIR PROCEDURE, BANKART REPAIR ON (B)(6) 2024, USING DRILL BIT (STABILIZATION) THERE WERE METAL SHAVINGS THAT CAME OFF INTO THE JOINT. IT WAS REPORTED THAT THE SHAVINGS FROM DRILL BIT WERE REMOVED VIA SHAVER/SUCTION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730738 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2023 THE TWO (X2) LUPINE STABILIZATION DRBT DEVICES DRILL BIT WAS USED AND WHEN IT BOTTOMED OUT SHAVINGS FROM THE DRILL BIT CAME OFF AND HAD TO BE CLEANED UP WITH THE SHAVER/SUCTION IN THE SHOULDER USING ANOTHER DRILL BIT FOR NEXT ANCHOR AND THE SAME THING OCCURRED. THERE WAS A TEN MINUTE SURGICAL DELAY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054553 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2023 THE TWO (X2) LUPINE STABILIZATION DRBT DEVICES DRILL BIT WAS USED AND WHEN IT BOTTOMED OUT SHAVINGS FROM THE DRILL BIT CAME OFF AND HAD TO BE CLEANED UP WITH THE SHAVER/SUCTION IN THE SHOULDER USING ANOTHER DRILL BIT FOR NEXT ANCHOR AND THE SAME THING OCCURRED. THERE WAS A TEN MINUTE SURGICAL DELAY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054550 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A BANKART REPAIR SURGICAL PROCEDURE ON (B)(6) 2023 THE LUPINE STABILIZATION DRBT DEVICE WAS BEING USED WHEN IT BOTTOMED OUT AND SHAVINGS FROM THE DRILL BIT CAME OFF AND HAD TO BE CLEANED UP WITH THE SHAVER/SUCTION IN THE SHOULDER. THERE WAS A 10 MINUTES SURGICAL DELAY WITH NO PATIENT CONSEQUENCES REPORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18024723 ↗
• MalfunctionJan 5, 2022Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE LUPINE STABILIZATION 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 13170745 ↗
• MalfunctionOct 12, 2020Break; Break

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A SHOULDER REPAIR A DRILL BIT (STABILIZATION) BROKE WHILE DRILLING. THEY CHANGED DRILL BIT TO COMPLETE PROCEDURE WITH A SURGICAL DELAY OF 5 MINUTES. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10667579 ↗
• MalfunctionSep 29, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE TWO DRILL BITS WERE DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICES WERE DISCARDED BY THE STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10602850 ↗
• MalfunctionSep 29, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE TWO DRILL BITS WERE DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICES WERE DISCARDED BY THE STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10602811 ↗
• InjurySep 25, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT THE LUPINE DRILL GUIDE TIP BROKE OFF WHILE DOCTOR WAS DRILLING INTO THE GLENOID. THE LUPINE DRILL TIP WAS LEFT IN THE GLENOID UNDER LUPINE IMPLANT. NO SURGERY DELAY. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE EVENT OCCURRED DURING A BANKART PROCEDURE AND A LOT NUMBER IS NOT KNOWN. IT WAS ALSO REPORTED THE BROKEN PIECE OF THE BIT IS NOT GOING TO REMOVED FORM THE PATIENT AND THE CASE WAS COMPLETED WITH A LIKE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10590855 ↗
• MalfunctionSep 17, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THE LUPINE STABILIZATION DRBT *EA. LUPINE DRILL BIT BROKE FROM THE TIP AND CAN'T BE USED. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE LOT NUMBER OF THE DEVICE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10549566 ↗
• MalfunctionJun 26, 2020Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS OBSERVED THAT TWO OF THE FISHMOUTH DRILL GUIDE AND TWO OF THE DRILL BIT (STABILIZATION) WERE DULL AND CREATED METAL SHAVINGS. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT´S BODY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201771 ↗
• MalfunctionJun 26, 2020Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS OBSERVED THAT TWO OF THE FISHMOUTH DRILL GUIDE AND TWO OF THE DRILL BIT (STABILIZATION) WERE DULL AND CREATED METAL SHAVINGS. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT´S BODY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201770 ↗
• MalfunctionMar 23, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR TWO OF THE DRILL BITS WERE DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICES WERE DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9869132 ↗
• MalfunctionMar 23, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR TWO OF THE DRILL BITS WERE DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICES WERE DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9868789 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S LUPINE FISHMOUTH DRILL GUIDE AND LUPINE DRILL BIT CREATED METAL SHAVINGS IN THE PATIENT'S JOINT SPACE. THE SALES REP STATED THAT THE METAL SHAVINGS WERE REMOVED WITH THE SHAVER AND THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE DEVICES AS THE ISSUE OCCURRED TOWARDS THE END OF THE CASE. THERE WAS NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICES ARE APPROXIMATELY FIVE YEARS OLD AND HAVE SEEN HEAVY USE IN THE FIELD. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9129713 ↗
• MalfunctionSep 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING SHOULDER REPAIR, IT WAS OBSERVED THAT THE PROXIMAL TIP OF THE CUSTOMER'S LUPINE STABILIZATION DRILL BIT BROKE OFF WHEN DRILLING. THE SALES REP STATED THAT IT¿S THE PIECE ABOVE THE STOPPER THAT TIGHTENS THE DRILL THAT BROKE OFF. THE SALES REP STATED THAT THE PIECE THAT BROKE OFF IS OUTSIDE THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE BY MALLETING THE DRILL BIT 2-3MM THE REST OF THE WAY DUE TO THE DEVICE WAS ALREADY IN THE BONE. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A MINUTE DELAY IN THE PROCEDURE. THE SALES REP STATED THAT THE LOT NUMBER APPEARS TO BE WORN OFF BUT STATED THAT THE DEVICE IS OVER A YEAR OLD AND HAS SEEN HEAVY USE IN THE FIELD. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. 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 7852223 ↗
• MalfunctionAug 7, 2018Break; Break

  DURING A SHOULDER REPAIR, THE DRILL BIT SNAPPED DURING USE ON PATIENT. NOTHING FELL INTO PATIENT. SURGEON JUST CARRIED ON WITH THE PROCEDURE DECIDING NOT TO GO FOR THE 3RD ANCHOR AS 2 ANCHORS WERE ENOUGH. CASE COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7759137 ↗
• MalfunctionJul 23, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THE ONE OF THE DRILL BITS BROKE. IT WAS REPORTED THAT THE SURGEON CHANGED TO 2ND DRILL BIT BUT IT ALSO BROKE. THEN THE SURGEON USED A 3RD DRILL BIT AND COMPLETED THE SURGERY. THERE WAS A FIVE MINUTE DELAY TO SURGERY. 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 7711431 ↗
• MalfunctionJul 23, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THE ONE OF THE DRILL BITS BROKE. IT WAS REPORTED THAT THE SURGEON CHANGED TO 2ND DRILL BIT BUT IT ALSO BROKE. THEN THE SURGEON USED A 3RD DRILL BIT AND COMPLETED THE SURGERY. THERE WAS A FIVE MINUTE DELAY TO SURGERY. 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 7711424 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DRILL BIT BROKE ON THE PROXIMAL END WHERE IT WOULD GO INTO THE DRILL. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE,. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF 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 7703862 ↗